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A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Phase II Study Of Capecitabine Plus Gemcitabine For Metastatic Renal Cell Carcinoma


- 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.

Inclusion Criteria


- 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

- 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

- 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)

- No concurrent palliative radiotherapy


- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered


- Any number of prior regimens allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
UCSF Comprehensive Cancer Center San Francisco, California  94115
Weill Medical College of Cornell University New York, New York  10021
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Missouri Baptist Cancer Center St. Louis, Missouri  63131