- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005870
Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus Most Appropriate Therapy in Refractory Pancreatic Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Ramon, California, United States, 94583
- SuperGen, Incorporated
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lawrence A. Romel, MS, Astex Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Alkylating Agents
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Topoisomerase I Inhibitors
- Gemcitabine
- Fluorouracil
- Rubitecan
- Mitomycins
- Mitomycin
Other Study ID Numbers
- CDR0000067906
- SUPERGEN-RFS2000-09
- RPCI-DS-99-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina
Clinical Trials on fluorouracil
-
The Netherlands Cancer InstituteCompleted
-
Sun Yat-sen UniversityZhejiang Cancer Hospital; Fudan University; Peking University Cancer Hospital... and other collaboratorsUnknownNasopharyngeal CarcinomaChina
-
Sun Yat-sen UniversityUnknown
-
CStone PharmaceuticalsActive, not recruitingUnresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell CarcinomaChina
-
Actavis Inc.CompletedActinic KeratosisUnited States
-
The Netherlands Cancer InstituteCompleted
-
Hui ting Xu,MDJiangsu HengRui Medicine Co., Ltd.UnknownClinical Study of Apatinib and 5-Fu Combination Regimen to Treat Advanced Colorectal Cancer PatientsMetastatic Colorectal CancerChina
-
Kansai Hepatobiliary Oncology GroupUnknownHepatocellular CarcinomaJapan
-
Melissa Pugliano-MauroNational Cancer Institute (NCI)RecruitingCarcinoma, Squamous CellUnited States
-
Hokkaido Gastrointestinal Cancer Study GroupHokkaido University HospitalCompleted