S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer

NCT00058318 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000288820U10CA032102S0312
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Kidney Cancer

Keywords

stage IV renal cell cancer; stage III renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Response

  every 8 weeks until progression

Secondary Outcomes (2)

• Survival

  every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years

• Time to treatment failure

  every 8 weeks until progression

Study Arms (1)

Treatment

EXPERIMENTAL

Gemcitabine + Capecitabine

Drug: capecitabine; Drug: gemcitabine hydrochloride

Interventions

capecitabine DRUG

Capecitabine will be given 625 mg/m\^2 (1250 mg/m\^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression

Treatment

gemcitabine hydrochloride DRUG

Gemcitabine will be given 900 mg/m\^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Related Publications (2)

• Van 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 RESULT

• van 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.

  RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Capecitabine; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Peter J. VanVeldhuizen, MD

  Kansas City Veteran Affairs Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: December 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: November 1, 2008
• Last Updated: November 2, 2012

Record last verified: 2012-10