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

Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma

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.

Study Overview

• Status: Completed
• Conditions: Pain; Gastric Cancer; Esophageal Cancer; Adenocarcinoma of the Gastroesophageal Junction; Nausea and Vomiting
• Intervention / Treatment: Drug: docetaxel; Radiation: radiation therapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: pain therapy; Drug: steroid therapy; Procedure: nausea and vomiting therapy; Procedure: standard follow-up care

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Bristol, England, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology Centre
    • Cambridge, England, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital
    • Coventry, England, United Kingdom, CV4 7AL
      • Warwick Medical School Clinical Trials Unit
    • Guildford, England, United Kingdom, GU2 7XX
      • St. Luke's Cancer Centre at Royal Surrey County Hospital
    • London, England, United Kingdom, NW1 2DA
      • Medical Research Council Clinical Trials Unit
    • Southampton, England, United Kingdom, SO14 0YG
      • Royal South Hants Hospital
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 2TL
      • Velindre Cancer Center at Velindre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Time to documented progression (arm I)
Response rate (arm I)
Toxicity (arm I)
Quality of life as assessed by EORTC QLQ-C30 and -STO22
Health economic evaluation as assessed by EQ-5D

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Hugo Ford, MD, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: pain; stage IV gastric cancer; recurrent gastric cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus; adenocarcinoma of the gastroesophageal junction; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; recurrent esophageal cancer; stage IV esophageal cancer; nausea and vomiting; stage IIIA gastric cancer; stage IIIB gastric cancer; stage IIIC gastric cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Signs and Symptoms, Digestive; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Nausea; Vomiting; Adenocarcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CRCA-COUGAR-02; CDR0000649670 (Registry Identifier: PDQ (Physician Data Query)); EudraCT-2006-005046-37; ISRCTN13366390; CRUK/07/013; EU-20969