S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00058318
First received: April 7, 2003
Last updated: October 31, 2012
Last verified: October 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Response [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival [ Time Frame: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | December 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Gemcitabine + Capecitabine
|
Drug: capecitabine
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
Drug: gemcitabine hydrochloride
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.
|
Detailed Description:
OBJECTIVES:
- Determine response (confirmed and unconfirmed complete and partial) of patients with advanced renal cell cancer treated with gemcitabine and capecitabine.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Correlate, preliminarily, tumor response with the intratumoral content of the enzymes involved in the activation and degradation of these drugs in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations More Information
Additional Information:
Publications:
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.
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00058318 History of Changes |
| Other Study ID Numbers: | CDR0000288820, U10CA032102, S0312 |
| Study First Received: | April 7, 2003 |
| Last Updated: | October 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage IV renal cell cancer stage III renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Gemcitabine Capecitabine |
Fluorouracil Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013