Trial · NCT00828139
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT00828139, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer. Trials, record NCT00828139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00828139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT00828139
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 189 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Interventions
- ziv-aflibercept, topotecan hydrochloride
- First posted
- 2009-01-23
- Last updated
- 2017-08-21
- Results first posted
- 2016-04-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Disease assessments were performed every 6 weeks, up to 2 years. | From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. |
| Secondary | Overall Survival | Weekly, up to 2 years. | Estimated to within at least 15% (95% confidence interval). |
| Secondary | Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) | Disease assessment for response were performed every 6 weeks, up to 2 years. | The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated after each cycle (21 days), up to 2 years. | Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Disease assessments were performed every 6 weeks, up to 2 years. | Months | MEDIAN | |
| SECONDARY | Overall Survival | Weekly, up to 2 years. | months | MEDIAN | |
| SECONDARY | Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) | Disease assessment for response were performed every 6 weeks, up to 2 years. | proportion of participants | NUMBER | |
| SECONDARY | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated after each cycle (21 days), up to 2 years. | Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 1.8 | 90% Confidence Interval 1.5 to 2.2 | Months | |
| Progression-free Survival (PFS) | Platinum Sensitivity Treated With Topotecan Alone | 1.3 | 90% Confidence Interval 1.2 to 1.4 | Months | |
| Progression-free Survival (PFS) | Platinum Refractory Treated With Topotecan + Ziv-aflibercept | 1.4 | 90% Confidence Interval 1.3 to 1.7 | Months | |
| Progression-free Survival (PFS) | Platinum Refractory Treated With Topotecan Aloine | 1.4 | 90% Confidence Interval 1.3 to 1.4 | Months | |
| Overall Survival | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 6.0 | 90% Confidence Interval 4.8 to 10.2 | months | |
| Overall Survival | Platinum Sensitivity Treated With Topotecan Alone | 4.6 | 90% Confidence Interval 2.9 to 5.3 | months | |
| Overall Survival | Platinum Refractory Treated With Topotecan + Ziv-aflibercept | 4.6 | 90% Confidence Interval 4.0 to 5.8 | months | |
| Overall Survival | Platinum Refractory Treated With Topotecan Aloine | 4.2 | 90% Confidence Interval 2.7 to 5.0 | months | |
| Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 0.02 | 90% Confidence Interval 0 to 0.11 | proportion of participants | |
| Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) | Platinum Sensitivity Treated With Topotecan Alone | 0 | 90% Confidence Interval 0 to 0.07 | proportion of participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 42 | |
| Overall Study | STARTED | Platinum Sensitivity Treated With Topotecan Alone | 41 | |
| Overall Study | STARTED | Platinum Refractory Treated With Topotecan + Ziv-aflibercept | 55 | |
| Overall Study | STARTED | Platinum Refractory Treated With Topotecan Aloine | 51 | |
| Overall Study | COMPLETED | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 1 | |
| Overall Study | COMPLETED | Platinum Sensitivity Treated With Topotecan Alone | 0 | |
| Overall Study | COMPLETED | Platinum Refractory Treated With Topotecan + Ziv-aflibercept | 0 | |
| Overall Study | COMPLETED | Platinum Refractory Treated With Topotecan Aloine | 0 | |
| Overall Study | NOT COMPLETED | Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept | 41 | |
| Overall Study | NOT COMPLETED | Platinum Sensitivity Treated With Topotecan Alone | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events230
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 | Hemoglobin | Blood and lymphatic system disorders | Ziv-aflibercept + Topotecan | 64 | 92 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Topotecan | 65 | 87 | |
| other | Constipation | Gastrointestinal disorders | Ziv-aflibercept + Topotecan | 34 | 92 | |
| other | Constipation | Gastrointestinal disorders | Topotecan | 31 | 87 | |
| other | Diarrhea | Gastrointestinal disorders | Ziv-aflibercept + Topotecan | 15 | 92 | |
| other | Diarrhea | Gastrointestinal disorders | Topotecan | 14 | 87 | |
| other | Distention/bloating, abdominal | Gastrointestinal disorders | Ziv-aflibercept + Topotecan | 5 | 92 | |
| other | Distention/bloating, abdominal | Gastrointestinal disorders | Topotecan | 2 | 87 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Ziv-aflibercept + Topotecan | 7 | 92 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Topotecan | 4 | 87 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziv-aflibercept + Topotecan | ||
| Total, all-cause mortality | Topotecan | ||
| Total, other adverse events | Ziv-aflibercept + Topotecan | 91 | 92 |
| Total, other adverse events | Topotecan | 86 | 87 |
| Total, serious adverse events | Ziv-aflibercept + Topotecan | 44 | 92 |
| Total, serious adverse events | Topotecan | 17 | 87 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ziv-aflibercept + Topotecan vs Topotecan: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00828139
GET https://conductscience.org/api/trials/v1/NCT00828139/results?page=2