Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: August 5, 2002
Last updated: July 7, 2015
Last verified: July 2015

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 Intervention Phase
Kidney Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2002
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
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  CDR0000069488 
Study First Received: August 5, 2002
Last Updated: July 7, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on February 04, 2016