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Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study

Phase 2
18 Years
70 Years
Open (Enrolling)
Kidney Cancer

Thank you

Trial Information

Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study

OBJECTIVES: I. Determine the toxic effects of interferon alfa, interleukin-2, gemcitabine,
and fluorouracil in patients with metastatic or unresectable renal cell cancer. II. Evaluate
the feasibility and possible therapeutic anticancer efficacy of this therapy in these
patients. III. Determine the duration of response, survival, and improvement of quality of
life in these patients.

OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine
IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered
subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is
administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course.
Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic
effects and disease progression. Following chemobiotherapy, maintenance therapy is
administered to patients with stable or responding disease. Patients receive subcutaneous
interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or
for a maximum of 1 year. A quality of life assessment is completed weekly. Patients are
followed until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18-24

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable carcinoma of the
kidney No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy:
Greater than 4 months Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least
2,500/mm3 Platelet count at least 100,000/mm3 PT no greater than 1.3 times upper limit of
normal (ULN) Hematocrit at least 28% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no
greater than 1.25 times ULN (unless due to tumor) Renal: Creatinine less than 2.0 mg/dL
Calcium less than 12 mg/dL Proteinuria no greater than 2.0 by dipstick Cardiovascular: No
active angina No uncontrolled congestive heart failure No uncontrolled arrhythmias No
myocardial infarction within 6 months Pulmonary: No significant pulmonary disease (RA pO2
less than 60 or pCO2 greater than 50) Other: Not pregnant or nursing Fertile patients must
use effective contraception HIV negative No active infection No daily emesis or inability
to tolerate solid foods No prior or concurrent second malignancy within 2 years, except:
Nonmelanoma skin cancer Carcinoma in situ of the cervix No sever diarrhea (greater than 4
watery stools per day) No active pelvic inflammatory disease No inflammatory bowel disease
No uncontrolled seizure disorders No personal or family history of malignant hyperthermia
No recent thromboembolism or any condition requiring concurrent anticoagulation

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy
Chemotherapy: No prior gemcitabine No prior fluorouracil other than adjuvant fluorouracil
received at least 1 year prior to study No other concurrent chemotherapy Endocrine
therapy: Concurrent corticosteroids not allowed (except for nausea or vomiting)
Radiotherapy: At least 14 days since prior radiation to axial skeleton No concurrent
radiotherapy (except to local lesions) Surgery: At least 14 days since prior exploration
and biopsy At least 21 days since prior resection with anastomosis No major organ
allograft Other: No concurrent barbiturates No concurrent oral anticoagulants No other
concurrent investigational drugs or devices

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gamini S. Soori, MD, FACP, FRCP, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

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



Bloomington Hospital Bloomington, Indiana  47402
Bergan Mercy Medical Center Omaha, Nebraska  68124