Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000069488

NCT ID:

NCT00042965

Start Date:

October 2002

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cedars-Sinai Medical CenterLos Angeles, California  90048
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Weill Medical College of Cornell UniversityNew York, New York  10021
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131