Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for cancer of unknown primary origin. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating patients with cancer of unknown primary origin.

Detailed Description
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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.

Official Title
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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

Conditions
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Carcinoma of Unknown Primary

Intervention / Treatment
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* Drug: carboplatin
* Drug: etoposide
* Drug: fluorouracil
* Drug: leucovorin calcium
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: etoposide|nan|
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of unknown primary, newly diagnosed carcinoma of unknown primary