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

This study is ongoing, but not recruiting participants.

Sponsored by: SuperGen
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005870
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether nitrocamptothecin is more effective than other chemotherapy for cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of other chemotherapy in treating patients who have recurrent or refractory cancer of the pancreas.


Condition Intervention Phase
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: mitomycin C
Drug: rubitecan
Phase III

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

Drug Information available for:   Gemcitabine hydrochloride    Gemcitabine    Fluorouracil    Camptothecin    Pancrelipase    Ultrase    Mitomycin    Mitomycins    Rubitecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005870

Locations
United States, California
SuperGen, Incorporated    
      San Ramon, California, United States, 94583
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators
SuperGen

Investigators
Study Chair:     Lawrence A. Romel, MS     SuperGen    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067906, SUPERGEN-RFS2000-09, RPCI-DS-99-11
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005870
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer  
adenocarcinoma of the pancreas  

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
9-nitrocamptothecin
Pancrelipase
Mitomycins
Recurrence
Camptothecin
Digestive System Diseases
Fluorouracil
Mitomycin
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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