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A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer - The ELECT Trial.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

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Trial Information

A Randomised Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer - The ELECT Trial.


OBJECTIVES:

Primary

- Compare the response rate in patients with advanced esophageal, gastroesophageal
junction, or gastric cancer treated with epirubicin hydrochloride, oxaliplatin, and
capecitabine vs docetaxel and oxaliplatin.

Secondary

- Compare the time to progression, survival, and quality of life of patients treated with
these regimens.

- Compare the toxicities associated with these regimens in these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive epirubicin hydrochloride IV over 10-15 minutes and oxaliplatin
IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21. Treatment
repeats every 3 weeks for up to 8 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires periodically.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction, or
lower third of the esophagus

- Unresectable or metastatic disease

- Measurable disease by CT scan

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Bilirubin ≤ 1.0 times upper limit of normal (ULN)

- AST and ALT ≤ 1.5 times ULN

- Hemoglobin > 10.0 g/dL

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent serious illness including, but not limited to, myocardial infarction
within the past 6 months, uncontrolled angina, uncontrolled hypertension, or severe
chronic obstructive pulmonary disease (> 3 admissions for infective exacerbation
within the past 12 months)

- No symptoms or signs of peripheral neuropathy

- No known second or third-degree heart block

- No other prior or concurrent malignancy except basal cell carcinoma of the skin or in
situ neoplasia of the uterine cervix

- No known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines

- No psychological, familial, sociological, or geographical condition that would
potentially hamper compliance with study treatment and follow-up schedule

PRIOR CONCURRENT THERAPY:

- No prior treatment for advanced disease

- More than 12 months since prior neoadjuvant/adjuvant therapy

- No other concurrent investigational agents

- Concurrent palliative radiotherapy allowed provided the site to be irradiated does
not include one of the target lesions used for response assessment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (partial and complete response) as assessed by CT scan

Safety Issue:

No

Principal Investigator

Martin Eatock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Belfast City Hospital Trust Incorporating Belvoir Park Hospital

Authority:

Unspecified

Study ID:

CDR0000629056

NCT ID:

NCT00806949

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer
  • recurrent gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • recurrent esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the gastroesophageal junction
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

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