Status:
COMPLETED
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 con...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00978549
Start Date
April 1 2008
End Date
October 1 2010
Last Update
August 7 2013
Active Locations (8)
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1
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
2
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
3
Warwick Medical School Clinical Trials Unit
Coventry, England, United Kingdom, CV4 7AL
4
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX