Chemotherapy in Treating Patients With Cancer of Unknown Primary Origin

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Ziekenhuis Maastricht
• Treatments: Albumin-Bound Paclitaxel; Calcium; Carboplatin; Etoposide; Etoposide phosphate; Fluorouracil; Leucovorin; Levoleucovorin; Paclitaxel

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