Clinical trial · Interventional
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
NCT00523640CI-TRIAL-00013724terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Too slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination of gemcitabine, capecitabine, and bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Combination 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
- interventionNames
- Drug: combination of gemcitabine, capecitabine, and bevacizumab
Primary outcomes (2)
- measure
- Objective Response Rate
- timeFrame
- 12 weeks
- description
- 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.
- measure
- Progression-free Survival
- timeFrame
- 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.