Clinical trial · Interventional
S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
NCT00058318CI-TRIAL-00008415completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced renal cell cancer (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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Gemcitabine + Capecitabine
- interventionNames
- Drug: capecitabine
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Response
- timeFrame
- every 8 weeks until progression
Secondary outcomes (2)
- measure
- Survival
- timeFrame
- every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
- measure
- Time to treatment failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma * Metastatic (M1) disease OR * M0 provided the primary tumor is unresectable * Measurable disease * At least 1 unidimensionally measurable lesion * Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease * Soft tissue disease within a prior radiation field is measurable provided it has progressed since therapy and there is also measurable disease outside of the irradiated field * No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN Renal * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other concurrent uncontrolled illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * No uncontrolled diabetes mellitus * No ongoing or active infection * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or interleukin-2 (IL-2) * At least 28 days since prior IFN or IL-2 and recovered Chemotherapy * No prior chemotherapy for renal cell cancer Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to 25% or more of the bone marrow * At least 21 days since prior radiotherapy and recovered Surgery * At least 28 days since prior surgery and recovered * Prior resection of the primary tumor allowed (in patients with metastatic disease) Other * At least 4 weeks since prior sorivudine or brivudine * No concurrent sorivudine or chemically related analogues (e.g., brivudine)
References
Publications (2)
- RESULTVan Veldhuizen PJ, Hussey M, Lara PN Jr, Mack PC, Gandour-Edwards R, Clark JI, Lange MK, Crawford DE. A phase ii study of gemcitabine and capecitabine in patients with advanced renal cell cancer: Southwest Oncology Group Study S0312. Am J Clin Oncol. 2009 Oct;32(5):453-9. doi: 10.1097/COC.0b013e3181925176. PMID 19487915
- RESULTvan Veldhuizen PJ, Hussey M, Lara PN, et al.: A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): results of Southwest Oncology Group study 0312. [Abstract] J Clin Oncol 25 (Suppl 18): A-15562, 654s, 2007.