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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

Phase 3
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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

Performance status:

- Karnofsky 60-100%

Life expectancy:

- 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


Biologic therapy:

- 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

Endocrine therapy:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

April 2005

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



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