Capecitabine and Gemcitabine in Treating Patients With Metastatic 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: NCT00042965
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with gemcitabine in treating patients who have metastatic kidney cancer.

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

Detailed Description:


  • Determine the objective response rate in patients with metastatic renal cell carcinoma treated with gemcitabine and capecitabine.
  • Determine the duration of overall and progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma
Study Start Date : October 2002
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Gemcitabine + capecitabine

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Drug: capecitabine
Drug: gemcitabine hydrochloride

Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 years ]
  2. Progression-free survival [ Time Frame: Up to 2 years ]

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.

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


  • Histologically confirmed renal cell carcinoma

    • Clinically confirmed metastatic disease (histologic documentation of metastatic disease not required)
  • Sarcomatoid renal cell carcinomas allowed
  • No pure sarcomas
  • No collecting duct (duct of Bellini) tumors, oncocytomas, or transitional cell tumors
  • Measurable disease

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Nonmeasurable lesions include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Patients with known brain metastases are eligible if they have undergone prior surgical resection and/or cranial irradiation, they currently do not require steroids or anticonvulsants, and there is no progressive disease on CT scan or MRI at least 4 weeks after completion of radiotherapy



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • 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


  • Creatinine clearance at least 30 mL/min


  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias not well controlled with medication
  • No myocardial infarction within the past 12 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study
  • No prior severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil
  • No malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract that would preclude absorption of capecitabine


Biologic therapy

  • Not specified


  • At least 4 weeks since prior chemotherapy and recovered
  • No prior gemcitabine
  • No prior fluoropyrimidines (e.g., fluorouracil, floxuridine, capecitabine, or fluorouracil-uracil)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior megestrol
  • No concurrent hormones (e.g., megestrol) except steroids for adrenal failure, hormones for nondisease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior radiotherapy to any lesion that may produce disability (e.g., unstable femur) allowed
  • No concurrent palliative radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered


  • Any number of prior regimens allowed

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): NCT00042965

  Show 50 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago

Publications of Results:
Stadler WM, Halabi S, Ernstoff MS, et al.: A phase II study of gemcitabine (G) and capecitabine (C) in patients with metastatic renal cell cancer (mRCC): a report of Cancer and Leukemia Group B #90008. [Abstract] J Clin Oncol 22 (Suppl 14): A-4515, 385s, 2004.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00042965     History of Changes
Other Study ID Numbers: CALGB-90008
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000069488 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs