COUGAR-02: A randomised phase III study of docetaxel vs active symptom control in patients with relapsed oesophago-gastric adenocarcinoma - COUGAR-02

Phase 1

• Conditions: Advanced oesophago-gastric cancer which has previously been treated with a platinum and fluoropyrimidine based combination; MedDRA version: 13.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1 Level: LLT Classification code 10001173 Term: Adenocarcinoma of esophagus System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-005046-37-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-07
• Study Completion: 2013-11-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 168

Inclusion Criteria

-Age >18 years -Histologically confirmed adenocarcinoma of the oesophagus or stomach (including adenocarcinoma of the oesophago-gastric junction) -Advanced disease not amenable to curative treatment -Documented progressive disease while receiving or within 6 months of completion of chemotherapy with a platinum and fluoropyrimidine or raltitrexed based therapy -Estimated life expectancy of at least 12 weeks -ECOG performance status 0,1 or 2 -Satisfactory hematological (Hb >10g/dL, WBC > 3.0 x 10 9/L, ANC > 1.5 x 10 9/L, Plt >100 x 10 9/L), renal (creatinine < ULN, or measured/calculated Creatinine clearance > 60ml/min) and hepatic (TBR < ULN, ALT < 1.5 x ULN, ALP < 5 x ULN) function -Ability to give informed consent -Completion of baseline QoL questionnaires (QLQ-C30,STO22 & EQ-5D) -Patients of both sexes with reproductive potential must employ barrier contraceptives whilst on treatment and for 3 months following completion of treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Cerebral or leptomeningeal metastasis -Prior chemotherapy with taxanes -Clinically significant peripheral neuropathy (Grade 2 to Grade 4) which in the view of the Investigator would be a contraindication to taxane therapy. -Previous malignancy within the 5 years prior trial entry except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia -Pregnant or lactating females

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether chemotherapy with docetaxel improves survival in patients with advanced gastric cancer previously treated with platinum/fluoropyrimidine or raltitrexed therapy.;Secondary Objective: Secondary endpoints are quality of life, progression free survival and toxicity;Primary end point(s): Overall survival