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Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin
in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the
toxicity, response rate, duration of response, time to progression, survival, performance
status, and weight associated with these treatment regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one
of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and
8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour
followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed every 6 weeks until disease progression, and then every 8 weeks until death.

PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or
locoregionally advanced (with metastatic lymph nodes) unresectable adenocarcinoma of the
exocrine pancreas Bidimensionally measurable disease outside previously irradiated fields
No CNS involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN) Renal: Creatinine
no greater than ULN Other: No prior second malignancy in the past 10 years except
carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin No
psychological, familial, sociological, or geographical condition that precludes study
compliance Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy
allowed if indicator lesions not included in irradiated field See Disease Characteristics
Surgery: Not specified Other: No concurrent investigational drugs

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Manfred Lutz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms