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Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Study NCT00042965   Information provided by National Cancer Institute (NCI)
First Received: August 5, 2002   Last Updated: July 23, 2008   History of Changes

August 5, 2002
July 23, 2008
October 2002
September 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00042965 on ClinicalTrials.gov Archive Site
 
 
 
Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

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.

OBJECTIVES:

  • 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.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 8-9 months.

Phase II
Interventional
Treatment, Open Label
Kidney Cancer
  • Drug: capecitabine
  • Drug: gemcitabine hydrochloride
 
Stadler WM, Halabi S, Rini B, Ernstoff MS, Davila E, Picus J, Barrier R, Small EJ; Cancer and Leukemia Group B. A phase II study of gemcitabine and capecitabine in metastatic renal cancer: a report of Cancer and Leukemia Group B protocol 90008. Cancer. 2006 Sep 15;107(6):1273-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
September 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • 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

Renal

  • Creatinine clearance at least 30 mL/min

Cardiac

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

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

Other

  • Any number of prior regimens allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00042965
 
CDR0000069488, CLB-90008
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
National Cancer Institute (NCI)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP