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

NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Nausea and Vomiting; Gastric Cancer; Esophageal Cancer; Adenocarcinoma of the Gastroesophageal Junction; Pain

Treatments: Procedure: standard follow-up care; Other: questionnaire administration; Radiation: radiation therapy; Procedure: quality-of-life assessment; Procedure: nausea and vomiting therapy; Drug: docetaxel; Drug: steroid therapy; Procedure: pain therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00978549

CRUK/07/013

EU-20969

CDR0000649670 (Registry Identifier)

EudraCT-2006-005046-37

CRCA-COUGAR-02

ISRCTN13366390

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

• To compare overall survival of patients with relapsed adenocarcinoma of the esophagus or stomach after treatment with docetaxel and active symptom control vs active symptom control alone.

Secondary

• To determine the time to documented progression in patients treated with docetaxel.
• To assess response rates to docetaxel in patients treated with docetaxel.
• To determine toxicity of docetaxel in patients treated with docetaxel.
• To assess the quality of life of these patients.
• To evaluate the health economic impact.

OUTLINE: This is a multicenter study.

Patients are stratified according to stage (locally advanced vs metastatic), site of disease (esophagus vs esophagogastric junction vs stomach), duration of response to prior chemotherapy (no response vs response duration < 3 months vs response duration 3-6 months), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on day 1 and active symptom control (e.g., analgesics [including opioids], antiemetics, steroids, palliative radiotherapy) daily.
• Arm II: Patients receive active symptom control as in arm I. Courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients in arm I undergo tissue biopsy collection at baseline and after 3 courses of treatment for biomarker analysis.

Quality of life is assessed by the QLQ-C30 and QLQ-STO22 questionnaires at baseline and at 3, 6, 9, 12, 18, and 24 weeks. Health resource use is assessed by the EQ-5D questionnaire at baseline and then periodically during and after treatment.

After completion of study treatment, patients are followed up every 6 weeks for 1 year and then every 3 months thereafter.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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