Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Over 18	Pharmaceutical / Industry	SUPERGEN-RFS2000-09 RPCI-DS-99-11, NCT00005870

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.

Entry 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  

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

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

Expected Enrollment

Approximately 400 patients (200 per arm) will be accrued for this study within 
15 months.

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.

Trial Contact Information

Trial Lead Organizations

SuperGen, Incorporated

Lawrence A. Romel, MS, Protocol chair		Ph: 925-560-0100 Email: LRomel@supergen.com

Registry Information
Official Title		Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients
Trial Start Date		1999-03-01
Registered in ClinicalTrials.gov		NCT00005870
Date Submitted to PDQ		2000-04-27
Information Last Verified		2007-06-12

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