Trial · NCT01130519
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
NCT01130519, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer. Trials, record NCT01130519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01130519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
- NCT number
- NCT01130519
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- HLRCC, Sporadic Papillary Renal Cell Cancer
- Interventions
- Bevacizumab, Erlotinib
- First posted
- 2010-05-26
- Last updated
- 2025-02-21
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months | Participants whose tumors regressed (Complete Response (CR) plus Partial Response (PR)) after therapy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the longest diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Data shown with 95% confidence intervals. |
| Secondary | Progression-free Survival | Amount of time subject survives without disease progression after treatment; a median of 15 months. | Median amount of time subject survives without disease progression after treatment. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Duration of Response | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented; a median of 19 months. | Duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Secondary | Overall Survival (OS) | Time from the date of study enrolment until time of death; a median of 29.3 months. | Overall survival is defined as the duration of time from the date of study enrolment until time of death estimated using a Kaplan Meier analysis. Participants without a death event will be censored at the date survival assessment was last evaluated (e.g., clinic visit, phone call). |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months | As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4). | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Amount of time subject survives without disease progression after treatment; a median of 15 months. | As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4). | Months | MEDIAN |
| SECONDARY | Duration of Response | Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented; a median of 19 months. | As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from the date of study enrolment until time of death; a median of 29.3 months. | As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4). | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 133 months and 13 days; and 119 months and 2 days for the first and second group respectively. | As pre-specified by the protocol for reporting purposes, our expansion cohorts were combined with the original cohorts (i.e., cohort 1, cohort 2, cohort 3, and cohort 4). Therefore, we reported on two groups: all Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) participants (Cohorts 1 \& 3) and all sporadic participants (Cohort 2 \& 4). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 72 | 95% Confidence Interval 57 to 83 | Percentage of participants | |
| Overall Response Rate | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 35 | 95% Confidence Interval 22 to 51 | Percentage of participants | |
| Progression-free Survival | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 21.1 | 95% Confidence Interval 15.6 to 26.6 | Months | |
| Progression-free Survival | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 8.9 | 95% Confidence Interval 5.5 to 18.3 | Months | |
| Duration of Response | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 19.3 | 95% Confidence Interval 12.9 to 35.9 | Months | |
| Duration of Response | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 18.4 | 95% Confidence Interval 13.8 to 49.7 | Months | |
| Overall Survival (OS) | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 44.6 | 95% Confidence Interval 32.7 to NA | Months | |
| Overall Survival (OS) | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 18.2 | 95% Confidence Interval 12.6 to 29.3 | Months | |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 43 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 40 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer | 20 | |
| Overall Study | STARTED | COHORT 2 - Sporadic Papillary Renal Cell Cancer | 21 | |
| Overall Study | STARTED | COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer | 23 | |
| Overall Study | STARTED | COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer | 19 | |
| Overall Study | COMPLETED | COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer | 20 | |
| Overall Study | COMPLETED | COHORT 2 - Sporadic Papillary Renal Cell Cancer | 21 | |
| Overall Study | COMPLETED | COHORT 3 - Hereditary Leiomyomatosis and Renal Cell Cancer Associated Kidney Cancer | 23 | |
| Overall Study | COMPLETED | COHORT 4-Sporadic/NonHereditary Leiomyomatosis and Renal Cell Cancer Papillary Kidney Cancer | 19 | |
| Overall Study | NOT COMPLETED | COHORT 1-Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis and Renal Cell Cancer | 0 | |
| Overall Study | NOT COMPLETED | COHORT 2 - Sporadic Papillary Renal Cell Cancer | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events768
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 | Abdominal distension | Gastrointestinal disorders | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 1 | 43 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 1 | 40 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 15 | 43 | 24 |
| other | Abdominal pain | Gastrointestinal disorders | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 6 | 40 | 10 |
| other | Activated partial thromboplastin time prolonged | Investigations | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 0 | 43 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 2 | 40 | 2 |
| other | Akathisia | Nervous system disorders | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 2 | 43 | 3 |
| other | Akathisia | Nervous system disorders | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 0 | 40 | 0 |
| other | Alanine aminotransferase increased | Investigations | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 16 | 43 | 46 |
| other | Alanine aminotransferase increased | Investigations | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 18 | 40 | 39 |
1 to 10 of 768Source ClinicalTrials.gov
See all 768 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 28 | 43 |
| Total, all-cause mortality | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 36 | 40 |
| Total, other adverse events | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 43 | 43 |
| Total, other adverse events | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 40 | 40 |
| Total, serious adverse events | COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer | 9 | 43 |
| Total, serious adverse events | COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer | 9 | 40 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer vs COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Trial comparisons |
| COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer vs COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer: deaths from any cause | Trial comparisons |
| COHORT 1&3 Advanced Renal Cell Cancer Associated With Hereditary Leiomyomatosis & Renal Cell Cancer vs COHORT 2 and 4 - Sporadic Papillary Renal Cell Cancer: serious adverse events | 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/NCT01130519
GET https://conductscience.org/api/trials/v1/NCT01130519/events?page=2