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

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
docetaxel
steroid therapy
questionnaire administration
nausea and vomiting therapy
pain therapy
quality-of-life assessment
standard follow-up care
radiation therapy
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital
  • Warwick Medical School Clinical Trials Unit
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Medical Research Council Clinical Trials Unit
  • Royal South Hants Hospital
  • Aberdeen Royal Infirmary
  • Velindre Cancer Center at Velindre Hospital

Outcomes

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

Full Information

First Posted
September 16, 2009
Last Updated
August 6, 2013
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00978549
Brief Title
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

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
steroid therapy
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
nausea and vomiting therapy
Intervention Type
Procedure
Intervention Name(s)
pain therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Time to documented progression (arm I)
Title
Response rate (arm I)
Title
Toxicity (arm I)
Title
Quality of life as assessed by EORTC QLQ-C30 and -STO22
Title
Health economic evaluation as assessed by EQ-5D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Ford, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Warwick Medical School Clinical Trials Unit
City
Coventry
State/Province
England
ZIP/Postal Code
CV4 7AL
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Medical Research Council Clinical Trials Unit
City
London
State/Province
England
ZIP/Postal Code
NW1 2DA
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

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

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