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Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus 5-Fluorouracil (5-FU) in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus 5-Fluorouracil (5-FU) in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment


OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer
after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit
and objective response rate to these treatment regimens in these patients. III. Compare and
evaluate time to treatment failure in these patients with these treatment regimens. IV.
Compare the toxicities of these treatment regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II:
Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8
courses in the absence of disease progression or unacceptable toxicity. Patients with tumor
regression or stabilization may receive additional courses of treatment. Patients with
disease progression or unacceptable toxicity may crossover to the alternate treatment arm.
Patients are followed every 3 months for one year.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory
adenocarcinoma of the pancreas Must have received prior gemcitabine and progressed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life
expectancy: At least 2 months Hematopoietic: Granulocyte count greater than 1,500/mm3
Hemoglobin at least 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT
no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor
involves liver) Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0
mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics At least 2 weeks since prior gemcitabine and recovered No prior
chemotherapy except gemcitabine No other concurrent chemotherapy Endocrine therapy: No
concurrent corticosteroids or hormones Radiotherapy: No concurrent radiotherapy Surgery:
At least 2 weeks since prior major surgery No major surgery within 8 weeks following
initiation of study treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Lawrence A. Romel, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Astex Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000067907

NCT ID:

NCT00005871

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

Name

Location

SuperGen, IncorporatedDublin, California  94568