Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients
OBJECTIVES: I. Compare the overall survival, objective response rate, time to treatment
failure, and time to progression in patients with recurrent or refractory adenocarcinoma of
the pancreas treated with oral nitrocamptothecin vs most appropriate chemotherapy. II.
Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-70% vs greater than 70%). Patients are
randomized to 1 of 2 treatment arms: Arm I: Patients receive oral nitrocamptothecin on days
1-5. Treatment repeats every week for 8 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease after week 8 may receive
additional courses. Arm II: Patients are stratified according to most appropriate therapy
possible (mitomycin or investigator's choice (including best supportive care) vs gemcitabine
vs fluorouracil). Patients who previously received fluorouracil and gemcitabine with or
without radiotherapy receive mitomycin or the investigator's choice of any proven or
experimental chemotherapy regimen previously submitted to the sponsor. Patients who
previously received fluorouracil only, other chemotherapy only, or fluorouracil with other
chemotherapy receive a proven or experimental regimen comprising gemcitabine. Patients who
previously received gemcitabine with other chemotherapy receive a proven or experimental
regimen comprising fluorouracil. Patients with stable or responding disease after week 8 may
receive additional courses if medically indicated. Patients for whom these drugs are not
indicated may receive best supportive care. At the time of disease progression, patients may
receive treatment with nitrocamptothecin. Patients are followed every 3 months for 1 year or
until death.
PROJECTED ACCRUAL: Approximately 400 patients (200 per arm) will be accrued for this study
within 15 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the
pancreas with failure or relapse after at least 1 prior chemotherapy regimen Ineligible if
only prior chemotherapy regimen consisted of gemcitabine alone or fluorouracil as a
radiosensitizer No prior nitrocamptothecin or other camptothecin analogs
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life
expectancy: At least 8 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3
Hemoglobin greater than 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and
SGPT no greater than 3 times normal (5 times normal if liver tumor present) 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: At least 2 weeks since prior immunotherapy and
recovered No concurrent filgrastim (G-CSF) with nitrocamptothecin No concurrent anticancer
immunotherapy Chemotherapy: See Disease Characteristics At least 2 weeks since prior
chemotherapy and recovered No other concurrent anticancer chemotherapy Endocrine therapy:
No concurrent anticancer hormonal therapy Radiotherapy: At least 2 weeks since prior
radiotherapy and recovered No concurrent anticancer radiotherapy Surgery: At least 2 weeks
since prior surgery and recovered No planned major surgery within 8 weeks after initiation
of 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:
CDR0000067906
NCT ID:
NCT00005870
Start Date:
March 1999
Completion Date:
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| SuperGen, Incorporated | Dublin, California 94568 |
