Carcinoma, Renal Cell
Conditions
Keywords
metastatic, renal cell, kidney, neoplasm
Brief summary
The purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.
Detailed description
* to determine the objective response rate and estimate the time to progression of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic clear cell renal cell cancer; * to determine survival of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic cell renal cell cancer; * to determine the toxicity of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic renal cell cancer; * to collect baseline serum and plasma samples for exploration of possible prognostic and predictive markers
Interventions
DRUGcombination of gemcitabine, capecitabine, and bevacizumab
gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle
Sponsors
Genentech, Inc.
Eli Lilly and Company
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed metastatic clear cell renal cell cancer * Measurable disease * Age 18 or older * ECOG performance status of 0 - 1 * Blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart * Normal organ function * Women of child-bearing potential and men must agree to use adequate contraception * Ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures
Exclusion criteria
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients may not have had prior treatment with pyrimidine analogs or VEGF binding agents * Patients may not be receiving any other investigational or therapeutic agents * Patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents Patients receiving low dose coumadin (1 mg daily) for central line patency are eligible * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study Fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable * Serious, nonhealing wound, ulcer, or bone fracture * Evidence of bleeding diathesis or coagulopathy * Patients with known brain metastases * Uncontrolled intercurrent illness * Pregnant women * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 12 weeks | Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR. |
| Progression-free Survival | 60 months | Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 60 months | Time from enrollment until death from any cause. |
Countries
United States
Participant flow
Recruitment details
30 patients were enrolled in the trial between March 2005 and May 2008
Participants by arm
| Arm | Count |
|---|---|
| Combination of Gemcitabine, Capecitabine, and Bevacizumab combination of gemcitabine, capecitabine, and bevacizumab | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Combination of Gemcitabine, Capecitabine, and Bevacizumab |
|---|---|
| Age, Continuous | 58 years |
| Fuhrman grade 1 | 0 participants |
| Fuhrman grade 2 | 2 participants |
| Fuhrman grade 3-4 | 21 participants |
| Fuhrman grade Unknown | 6 participants |
| Number of metastatic disease sites 1 | 2 participants |
| Number of metastatic disease sites 2 | 6 participants |
| Number of metastatic disease sites 3 or more | 21 participants |
| Performance Status 0 | 5 participants |
| Performance Status 1 | 23 participants |
| Performance Status 2 | 1 participants |
| Prior therapy-Cytokine therapy No | 21 participants |
| Prior therapy-Cytokine therapy Yes | 8 participants |
| Prior therapy-Nephrectomy No | 5 participants |
| Prior therapy-Nephrectomy Yes | 24 participants |
| Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor No | 9 participants |
| Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor Yes | 20 participants |
| Prior therapy-Radiotherapy No | 14 participants |
| Prior therapy-Radiotherapy Yes | 15 participants |
| Prognostic risk group Favorable | 7 participants |
| Prognostic risk group Intermediate | 19 participants |
| Prognostic risk group Poor | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 24 Participants |
| Tumor histology Clear cell | 23 participant |
| Tumor histology Poorly differentiated/unclassified | 6 participant |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 29 |
| serious Total, serious adverse events | 5 / 29 |
Outcome results
Primary
Objective Response Rate
Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination of Gemcitabine, Capecitabine, and Bevacizumab | Objective Response Rate | 0.24 proportion |
95% CI: [0.1, 0.44]
Primary
Progression-free Survival
Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline
Time frame: 60 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination of Gemcitabine, Capecitabine, and Bevacizumab | Progression-free Survival | 5.3 months |
Secondary
Overall Survival
Time from enrollment until death from any cause.
Time frame: 60 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination of Gemcitabine, Capecitabine, and Bevacizumab | Overall Survival | 9.8 months |