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

October 31, 2012 updated by: Southwest Oncology Group

A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: every 8 weeks until progression
every 8 weeks until progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
Time to treatment failure
Time Frame: every 8 weeks until progression
every 8 weeks until progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Peter J. VanVeldhuizen, MD, Kansas City Veteran Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000288820
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0312 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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