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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005046-37-GB

Enrollment

180

Registered

2007-11-07

Start date

2007-12-28

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Taxotere Product Name: Docetaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel C

Eligibility

Sex/Gender

All

Inclusion criteria

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 60ml/min) and hepatic (TBR =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026