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

NCT00978549 | Completed Phase 3

• 6 other identifiers: CRCA-COUGAR-02CDR0000649670EudraCT-2006-005046-37ISRCTN13366390CRUK/07/013EU-20969
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Keywords

pain; nausea and vomiting; adenocarcinoma of the esophagus; adenocarcinoma of the stomach; adenocarcinoma of the gastroesophageal junction; recurrent gastric cancer; stage IIIA gastric cancer; stage IIIB gastric cancer; stage IIIC gastric cancer; stage IV gastric cancer; recurrent esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (5)

• 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

Interventions

docetaxel DRUG

steroid therapy DRUG

questionnaire administration OTHER

nausea and vomiting therapy PROCEDURE

pain therapy PROCEDURE

quality-of-life assessment PROCEDURE

standard follow-up care PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (8)

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Warwick Medical School Clinical Trials Unit

Coventry, England, CV4 7AL, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Nausea; Vomiting; Pain; Adenocarcinoma Of Esophagus

Interventions

Docetaxel; Analgesia; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Anesthesia and Analgesia; Therapeutics

Study Officials

• Hugo Ford, MD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2009-09

Locations

GB (8)