Gemcitabine in Treating Patients With Metastatic Cancer of Unknown Primary

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

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with metastatic cancer of unknown primary.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed poorly differentiated carcinoma or adenocarcinoma of unknown primary

• Diagnosis based on biopsy and conventional imaging, including CT scans of the chest, abdomen, and pelvis with or without positron emission tomography (PET) scans or other specialized tests, performed within the past 4 weeks

• Must not have any of the following clinical features:

• Squamous cell carcinoma in the lymph nodes of the neck or inguinal nodes only

• Women with axillary lymph node metastases only

• Women with peritoneal carcinomatosis only

• Well-differentiated neuroendocrine tumors

• Poorly differentiated tumors with midline tumor or elevated human chorionic gonadotropin (HCG)/alpha-fetoprotein (AFP)

• Men with adenocarcinoma and elevated prostate-specific antigen (PSA)

• Measurable disease

• No symptom emergency at the time of study entry including, but not limited to, the following:

• Back pain with epidural cord compression

• Large effusions causing distress

• Hypercalcemia

• Bowel obstruction

• Very painful (worst pain 10/10) solitary bone metastases with impending fracture

PATIENT CHARACTERISTICS:

• Modified "Physical Well-Being" subscale of the FACT-G score ≥ 6 within the past week

• Pain-intensity score ≥ 20 mm on the Memorial Pain Assessment Card OR receiving analgesics of ≥ 10 mg per day of oral morphine equivalent within the past week

• ECOG performance status 1-2

• WBC ≥ 3,000/mm³

• Platelet count ≥ 100,000/mm³

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to read, understand, and complete the quality of life and symptom questionnaires, and perception of change

• Able to complete the analgesic diary on a daily basis

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiation therapy