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Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Gemcitabine HCl in Chemonaive Pancreatic Cancer Patients


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 Gemcitabine HCl in Chemonaive Pancreatic Cancer Patients


OBJECTIVES: I. Compare the overall survival, time to treatment failure, clinical benefit
response rate (analgesic consumption, pain intensity, performance status, and weight
change), and objective response rate in chemotherapy-naive patients with unresectable
locally advanced or metastatic adenocarcinoma of the pancreas treated with oral
nitrocamptothecin vs gemcitabine. II. Compare the toxicity of these 2 regimens in these
patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to measurable disease (yes vs no), Karnofsky performance status (50-70% vs
70-100%), and prior radiotherapy. 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 receive
gemcitabine IV over 30 minutes on day 1. Treatment repeats every week for 7 courses in the
absence of disease progression or unacceptable toxicity. Patients then undergo 1 week of
rest. Patients with stable or responding disease after week 8 may receive gemcitabine IV
over 30 minutes on days 1, 8, and 15. Courses repeat every 4 weeks. Pain is assessed within
7 days prior to study, at days 28 and 56 during study, and then every 28 days after
completion of study. Patients are followed every 3 months for 1 year or until death.

PROJECTED ACCRUAL: Approximately 994 patients (497 per arm) will be accrued for this study
within 22 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable locally
advanced (stage II or III) or metastatic (stage IV) adenocarcinoma of the pancreas

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life
expectancy: Not specified 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 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 3 weeks since prior immunotherapy and
recovered No filgrastim (G-CSF) concurrent with nitrocamptothecin Concurrent epoetin alfa
allowed Chemotherapy: Prior fluorouracil as radiosensitizer allowed No other prior
chemotherapy (e.g., nitrocamptothecin or gemcitabine) No other concurrent chemotherapy
Endocrine therapy: No concurrent hormonal or corticosteroid therapy Patients requiring
hormonal therapy or corticosteroid therapy for medical reasons may remain on study, but
will not be evaluable for clinical benefit response Radiotherapy: At least 3 weeks since
prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease
Characteristics More than 2 weeks since prior major surgery and recovered Prior stent
placement allowed No planned 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:

CDR0000067905

NCT ID:

NCT00005869

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location
SuperGen, Incorporated Dublin, California  94568