Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping to control symptoms caused by cancer. It is not yet known whether these treatments are more effective when given with or without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

PURPOSE: This randomized phase II trial is studying symptom control given together with docetaxel to see how well it works compared with symptom control given without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.

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

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the esophagus or stomach, including adenocarcinoma of the esophagogastric junction

• Advanced disease not amenable to curative treatment

• Documented progressive disease while receiving or within 6 months of completion of first-line chemotherapy with a platinum- and fluoropyrimidine-based therapy either for advanced disease or as neoadjuvant/perioperative therapy

• No cerebral or leptomeningeal metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Hemoglobin ≥ 10 g/dL

• WBC ≥ 3.0 x 10^9/L

• ANC ≥ 1.5 x 10^9/L

• Platelets ≥ 100 x 10^9/L

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• Total bilirubin normal

• ALT ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 3 months after completion of treatment

• No clinically significant peripheral neuropathy (grade 2-4)

• No prior malignancy except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia

• No medical or psychiatric condition that would influence the ability of patients to provide informed consent

• No other serious or uncontrolled illness that, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy with taxanes

• ≤ 1 prior chemotherapy regimen in advanced setting allowed