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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978549
• Other study ID #: CRCA-COUGAR-02
• Secondary ID: CDR0000649670Eud
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2009
• Last updated: August 6, 2013
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Gastroesophageal Junction
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Nausea and Vomiting
• Pain
• Stomach Neoplasms

Intervention

Drug:
• docetaxel

• steroid therapy

Other:
• questionnaire administration

Procedure:
• nausea and vomiting therapy

• pain therapy

• quality-of-life assessment

• standard follow-up care

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Warwick Medical School Clinical Trials Unit	Coventry	England
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Medical Research Council Clinical Trials Unit	London	England
United Kingdom	Royal South Hants Hospital	Southampton	England

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Time to documented progression (arm I)			No
Secondary	Response rate (arm I)			No
Secondary	Toxicity (arm I)			Yes
Secondary	Quality of life as assessed by EORTC QLQ-C30 and -STO22			No
Secondary	Health economic evaluation as assessed by EQ-5D			No