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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058318
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : November 2, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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).

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: capecitabine Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : November 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Response [ Time Frame: every 8 weeks until progression ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years ]
  2. Time to treatment failure [ Time Frame: every 8 weeks until progression ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN


  • Creatinine clearance at least 50 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


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


  • No prior chemotherapy for renal cell cancer

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy to 25% or more of the bone marrow
  • At least 21 days since prior radiotherapy and recovered


  • At least 28 days since prior surgery and recovered
  • Prior resection of the primary tumor allowed (in patients with metastatic disease)


  • At least 4 weeks since prior sorivudine or brivudine
  • No concurrent sorivudine or chemically related analogues (e.g., brivudine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058318

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Peter J. VanVeldhuizen, MD Kansas City Veteran Affairs Medical Center
Publications of Results:
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.

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Responsible Party: Southwest Oncology Group Identifier: NCT00058318    
Other Study ID Numbers: CDR0000288820
U10CA032102 ( U.S. NIH Grant/Contract )
S0312 ( Other Identifier: SWOG )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: October 2012
Keywords provided by Southwest Oncology Group:
stage IV renal cell cancer
stage III renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs