A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
18 Years
N/A
Both
Carcinoma of Unknown Primary
Trial Information
A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
OBJECTIVES:
- Compare the overall survival after treatment with paclitaxel, carboplatin, and
etoposide and after treatment with fluorouracil and leucovorin calcium in patients with
adenocarcinoma of unknown primary.
- Compare the response rates, progression free survival, toxicity profile, and quality of
life between the two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and
presence or absence of liver metastases.
Patients are randomly assigned to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on
day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to
four courses.
- Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV
over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two
courses.
Patients are followed every 3 months after treatment for 1 year or until death. Quality of
life questionnaires are completed at each follow-up.
PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of any differentiation grade
- Excludes the following "treatable" conditions:
- Axillary node involvement
- Peritonitis carcinomatosis
- Blastic bone metastases and/or elevated PSA
- Squamous cell cancer with cervical or inguinal presentation
- Poorly differentiated carcinoma
- Neuroendocrine tumors OR
- Tumors located in the mediastinum, retroperitoneum, or nodes
- At least one measurable metastatic site
- No brain or meningeal metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Hematopoietic:
- Leukocyte count at least 4,000/mm3
- Thrombocyte count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.4 mg/dL
- AST and ALT less than 3 times upper limit of normal
- No cirrhosis of the liver
Renal:
- Creatinine less than 1.7 mg/dL
Cardiovascular:
- At least 3 months since myocardial infarction
- No congestive heart failure, tachydysrhythmia, or unstable angina pectoris
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No active infection
- No other serious illness or medical condition
- No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in
situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow)
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
R. L. Jansen, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Academisch Ziekenhuis Maastricht
Authority:
United States: Federal Government
Study ID:
CDR0000066622
NCT ID:
NCT00003558
Start Date:
August 1998
Completion Date:
Related Keywords:
- Carcinoma of Unknown Primary
- adenocarcinoma of unknown primary
- newly diagnosed carcinoma of unknown primary
- Adenocarcinoma
- Carcinoma
- Neoplasms, Unknown Primary
Name | Location |
|---|
