Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00023972

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 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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: exatecan mesylate Drug: gemcitabine hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Exatecan Exatecan mesylate

U.S. FDA Resources

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

Study Start Date:

July 2001

Detailed Description:

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

Creatinine no greater than 1.5 times ULN

Cardiovascular:

No active congestive heart failure
No uncontrolled angina
No myocardial infarction

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

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

Surgery:

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

Other:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023972

Show 74 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Chair:

Robert L. DeJager, MD, FACP

Daiichi Sankyo Inc.

More Information

Additional Information:

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

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.

ClinicalTrials.gov Identifier:	NCT00023972 History of Changes
Other Study ID Numbers:	CDR0000068880, DAIICHI-8951A-PRT031, MSKCC-02011
Study First Received:	September 13, 2001
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Exatecan
Camptothecin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012