Gemcitabine With Or Without Exatecan Mesylate In Treating Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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 if gemcitabine is more effective with or without exatecan mesylate in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine alone to that of gemcitabine and exatecan mesylate in treating patients who have locally advanced or metastatic pancreatic cancer.

OBJECTIVES: * Compare the overall survival of patients with chemotherapy-naive locally advanced or metastatic cancer of the exocrine pancreas treated with exatecan mesylate and gemcitabine versus gemcitabine alone. * Compare the measures of clinical benefit in patients treated with these regimens. * Compare the anti-tumor efficacy of these regimens in this patient population. * Determine the safety profile of exatecan mesylate and gemcitabine in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (60% vs 70-80% vs 90-100%), extent of disease (locally advanced vs metastatic), and prior radiotherapy for pancreatic cancer (yes or no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes immediately followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine IV over 30 minutes once weekly for up to 7 weeks followed by one week of rest (course 1). For all subsequent courses, patients receive gemcitabine once weekly for 3 weeks followed by one week of rest. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 340 patients (170 per treatment arm) will be accrued for this study within 18 months.

Pancreatic Cancer

DRUG: exatecan mesylate
DRUG: gemcitabine hydrochloride

CDR0000068880
DAIICHI-8951A-PRT031
MSKCC-02011

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-09-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-05-15
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-05-16
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2012-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas

Locally advanced (unresectable) or metastatic disease
No islet cell tumor, lymphoma, or sarcoma of the pancreas
No known brain metastases

18 and over

Karnofsky 60-100%

Not specified

Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 5 times ULN
Albumin at least 2.8 g/dL

Creatinine no greater than 1.5 times ULN

No active congestive heart failure
No uncontrolled angina
No myocardial infarction

No serious infection or life-threatening illness unrelated to tumor
No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No overt psychosis or incompetency that would preclude study
No history of a positive serology for HIV
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use contraception

No prior systemic anticancer immunotherapy for pancreatic cancer
No concurrent anticancer immunotherapy or other biologic therapy

No prior systemic anticancer chemotherapy for pancreatic cancer
Prior fluorouracil as a radiosensitizer allowed
No prior gemcitabine as a radiosensitizer
No other concurrent anticancer chemotherapy

Concurrent megestrol for appetite stimulation allowed

At least 28 days since prior radiotherapy and recovered
No prior radiotherapy to more than 25% of estimated bone marrow reserve
No concurrent anticancer radiotherapy

At least 28 days since prior major surgery and recovered
No concurrent surgery for cancer

No prior investigational or other systemic anticancer therapy for pancreatic cancer
No other concurrent investigational drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Robert L. DeJager, MD, FACP, Daiichi Sankyo

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Abou-Alfa GK, Letourneau R, Harker G, Modiano M, Hurwitz H, Tchekmedyian NS, Feit K, Ackerman J, De Jager RL, Eckhardt SG, O'Reilly EM. Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol. 2006 Sep 20;24(27):4441-7. doi: 10.1200/JCO.2006.07.0201.

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