Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

Sponsor

Academisch Ziekenhuis Maastricht (Other)

Overall Status

Unknown status

CT.gov ID

NCT00003558

Collaborator

(none)

140

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of Unknown Primary	Drug: carboplatin Drug: etoposide Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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