search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
capecitabine
gemcitabine hydrochloride
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, stage III renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Gemcitabine + Capecitabine

    Outcomes

    Primary Outcome Measures

    Response

    Secondary Outcome Measures

    Survival
    Time to treatment failure

    Full Information

    First Posted
    April 7, 2003
    Last Updated
    October 31, 2012
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00058318
    Brief Title
    S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer
    Official Title
    A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Cancer
    Keywords
    stage IV renal cell cancer, stage III renal cell cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Gemcitabine + Capecitabine
    Intervention Type
    Drug
    Intervention Name(s)
    capecitabine
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine hydrochloride
    Intervention Description
    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 Measure Information:
    Title
    Response
    Time Frame
    every 8 weeks until progression
    Secondary Outcome Measure Information:
    Title
    Survival
    Time Frame
    every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
    Title
    Time to treatment failure
    Time Frame
    every 8 weeks until progression

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter J. VanVeldhuizen, MD
    Organizational Affiliation
    Kansas City Veteran Affairs Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19487915
    Citation
    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.
    Results Reference
    result
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs