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
carboplatin
+ etoposide
+ fluorouracil
Neoplasm Metastasis+3
+ Neoplasms
+ Neoplastic Processes
Treatment Study
Summary
Study start date: August 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Academisch Ziekenhuis Maastricht
Maastricht, NetherlandsOpen Academisch Ziekenhuis Maastricht in Google MapsSt. Elisabeth Ziekenhuis
Tilburg, Netherlands