Trial · NCT02357810
Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
NCT02357810, Phase 2, Completed, Northwestern University; results first posted 2020-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas. Trials, record NCT02357810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02357810
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas
- NCT number
- NCT02357810
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 178 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Adult Liposarcoma, Metastatic Liposarcoma, Metastatic Osteosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Liposarcoma, Recurrent Osteosarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- Pazopanib Hydrochloride, Oral Topotecan Hydrochloride, Laboratory Biomarker Analysis
- First posted
- 2015-02-06
- Last updated
- 2022-06-07
- Results first posted
- 2020-08-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival at 12 Weeks for Patients With Soft Tissue Sarcoma (STS) Treated With Pazopanib and Oral Topotecan | At 12 weeks from treatment initiation | PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1 and measured at 12 weeks after treatment initiation for patients with STS. PFS estimates will be calculated using Kaplan-Meier methods Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression. |
| Secondary | Overall Response Rate (ORR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. | ORR is defined as the percentage of patients with Complete Response (CR) plus those with Partial Response (PR) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients best response to treatment will be used in ORR. Complete Response - Disappearance of all target and non target lesions Partial Response - At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD |
| Secondary | Clinical Benefit Rate (CBR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. | CBR is defined as the percentage of patients with Complete Response (CR) plus those with Partial Response (PR) plus those with Stable Disease (SD) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients best response to treatment will be used in CBR where, in general the following definitions are used: Complete Response - Disappearance of all target and non target lesions Partial Response - At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. |
| Secondary | Overall Survival (OS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment where one cycle = 28 days and range of cycles completed by patients 1-33, then for 2 years (for patients with progression) and 5 years (for patients without progression) following discontinuation of treatment | OS will be defined from start of study until death from any cause and estimates will be calculated using Kaplan-Meier methods. At time of Kaplan-meier calculations patients included the analysis who have not experienced the event will be censored at the last date of documentation of survival status. |
| Secondary | Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | From treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles | Toxicities will be tabulated and summarized by the number of patients experiencing each toxicity at grade 3 or grade 4 |
| Secondary | Median Progression Free Survival (PFS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. And then for up to 5 years post treatment discontinuation. | PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1. PFS estimates will be calculated using Kaplan-Meier methods. Patients included in the analysis, who did not experiences the event at the time of the calculation were censored from the last documentation of being progression free. Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression. |
| Secondary | Progression Free Survival in Patients With Osteosarcoma Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then for up to 5 years post treatment discontinuation | PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1. PFS estimates will be calculated using Kaplan-Meier methods. Patients included in the analysis, who did not experiences the event at the time of the calculation were censored from the last documentation of being progression free. Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression. |
| Secondary | Progression Free Survival for Patients With Liposarcoma Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then up to 5 years post treatment discontinuation. | PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1. PFS estimates will be calculated using Kaplan-Meier methods. Patients who did not experiences the event at the time of the calculation were censored from the last documentation of being progression free. Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression. |
| Other | Change in Cytokine Levels | Baseline to 12 weeks | Verification of results of Sleijfer et al and to determine if there is an even earlier correlation that can be detected between levels of these cytokines and PFR as well as OS which may allow us to better predict treatment response early on in therapy. |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival at 12 Weeks for Patients With Soft Tissue Sarcoma (STS) Treated With Pazopanib and Oral Topotecan | At 12 weeks from treatment initiation | Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable. | percentage of patients progression free | NUMBER |
| SECONDARY | Overall Response Rate (ORR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. | Patients with Soft Tissue Sarcoma treated on study eligible for this endpoint, even if there are major protocol treatment deviations or patients exhibit objective disease progression prior to the end of cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Rate (CBR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. | Patients with Soft Tissue Sarcoma treated on study eligible for this endpoint, even if there are major protocol treatment deviations or patients exhibit objective disease progression prior to the end of cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment where one cycle = 28 days and range of cycles completed by patients 1-33, then for 2 years (for patients with progression) and 5 years (for patients without progression) following discontinuation of treatment | Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable. | months | MEDIAN |
| SECONDARY | Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | From treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles | patients | NUMBER | |
| SECONDARY | Median Progression Free Survival (PFS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. And then for up to 5 years post treatment discontinuation. | Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable. | months | MEDIAN |
| SECONDARY | Progression Free Survival in Patients With Osteosarcoma Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then for up to 5 years post treatment discontinuation | Only patients with Osteosarcoma were eligible for this endpoint. | months | MEDIAN |
| SECONDARY | Progression Free Survival for Patients With Liposarcoma Treated With Combination Pazopanib and Topotecan. | During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then up to 5 years post treatment discontinuation. | Patients with liposarcoma were eligible for this endpoint. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in Cytokine Levels | Baseline to 12 weeks | |||
| POST_HOC | Overall Survival of Patients With Liposarcoma Treated With With Pazopanib and Oral Topotecan Combination | During treatment, where one cycle = 28 days and range of cycles completed by patients 1-33. Then for up to 5 years post treatment discontinuation. | At the time of the calculation, 12 events were seen out of a possible 16. | Weeks | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival at 12 Weeks for Patients With Soft Tissue Sarcoma (STS) Treated With Pazopanib and Oral Topotecan | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 57.5 | percentage of patients progression free | ||
| Overall Response Rate (ORR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 7 | Participants | ||
| Clinical Benefit Rate (CBR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 66 | Participants | ||
| Overall Survival (OS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan. | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 10.94 | 95% Confidence Interval 9.30 to 18.73 | months | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Anemia | 32 | patients | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Platelet count decreased | 61 | patients | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Decreased neutrophil count | 80 | patients | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Hypertension | 35 | patients | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Fatigue | 13 | patients | |
| Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | Nausea | 5 | patients |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Registered and Started Treatment | STARTED | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 178 | |
| Registered and Started Treatment | Signed Consent | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 178 | |
| Registered and Started Treatment | Registered to Study | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 152 | |
| Registered and Started Treatment | Initiated Treatment on Study | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 151 | |
| Registered and Started Treatment | COMPLETED | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 151 | |
| Registered and Started Treatment | NOT COMPLETED | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 27 | |
| Reached 12 Weeks Response | STARTED | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 151 | |
| Reached 12 Weeks Response | Completed 4 Weeks/1 Cycle | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 151 | |
| Reached 12 Weeks Response | Reached 6 Week Response | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 129 | |
| Reached 12 Weeks Response | Reached 12 Weeks/3 Cycles | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 95 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events310
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 112 | 151 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 5 | 151 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 2 | 151 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 6 | 151 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 1 | 151 | |
| other | Aortic valve disease | Cardiac disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 1 | 151 | |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 1 | 151 | |
| other | Atrioventricular block first degree | Cardiac disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 1 | 151 | |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 1 | 151 | |
| other | Chest pain - cardiac | Cardiac disorders | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 6 | 151 |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 116 | 151 |
| Total, other adverse events | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 151 | 151 |
| Total, serious adverse events | Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) | 88 | 178 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31401903 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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