Clinical trial NCT00978549: Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
Official title: Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Nausea and Vomiting
Pain
Keywords: pain
nausea and vomiting
adenocarcinoma of the esophagus
adenocarcinoma of the stomach
adenocarcinoma of the gastroesophageal junction
recurrent gastric cancer
stage IIIA gastric cancer
stage IIIB gastric cancer
stage IIIC gastric cancer
stage IV gastric cancer
recurrent esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer
stage IV esophageal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-09-17
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Time to documented progression (arm I)
measure: Response rate (arm I)
measure: Toxicity (arm I)
measure: Quality of life as assessed by EORTC QLQ-C30 and -STO22
measure: Health economic evaluation as assessed by EQ-5D
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Coventry
country: United Kingdom
facility: Warwick Medical School Clinical Trials Unit
state: England
city: Guildford
country: United Kingdom
facility: St. Luke's Cancer Centre at Royal Surrey County Hospital
state: England
city: London
country: United Kingdom
facility: Medical Research Council Clinical Trials Unit
state: England
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Hugo Ford, MD
role: PRINCIPAL_INVESTIGATOR
References: