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

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00978549

Collaborator

(none)

320

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Gastric Cancer Nausea and Vomiting Pain	Drug: docetaxel Drug: steroid therapy Other: questionnaire administration Procedure: nausea and vomiting therapy Procedure: pain therapy Procedure: quality-of-life assessment Procedure: standard follow-up care Radiation: radiation therapy	Phase 3

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Medical Research Council Clinical Trials Unit	London	England	United Kingdom	NW1 2DA
6	Royal South Hants Hospital	Southampton	England	United Kingdom	SO14 0YG
7	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
8	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales	United Kingdom	CF14 2TL