S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00096031
First received: November 9, 2004
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.


Condition Intervention Phase
Esophageal Cancer
Biological: cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival at 6 Months [ Time Frame: every 3 weeks while on treatment, then every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: every 3 weeks while on treatment ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2004
Study Completion Date: January 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Biological: cetuximab
1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other Name: Erbitux

Detailed Description:

OBJECTIVES:

  • Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.
  • Determine the response rate (confirmed and unconfirmed, complete and partial), time to progression, and time to treatment failure in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis with time to progression, response, overall survival, toxic effects, and time to treatment failure in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months until 3 years from the date of study registration.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of 1 of the following sites:

    • Thoracic esophagus, located > 20 cm* from the incisors
    • Gastroesophageal junction, located ≤ 2 cm into the gastric cardia NOTE: *Tumors located < 26 cm from the incisors must be confirmed by bronchoscopy and negative cytology
  • Disease confined to the esophagus and periesophageal soft tissue
  • Metastatic disease
  • Measurable disease by x-ray, scanning, or physical examination
  • Received exactly 1 prior chemotherapy regimen for metastatic or recurrent disease

    • One prior adjuvant or neoadjuvant chemotherapy regimen allowed if administered at the time of initial diagnosis with localized disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine ≤ 1.5 times upper limit of normal

Other

  • No prior allergic reaction to chimerized or murine monoclonal antibodies
  • No evidence of human anti-mouse antibodies (HAMA)
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior cetuximab

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • At least 3 weeks since prior thoraco-abdominal surgery and recovered

Other

  • No other prior therapy that specifically targets the epidermal growth factor pathway
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096031

  Show 152 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Philip J. Gold, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Study Chair: Syma Iqbal, MD University of Southern California
  More Information

Additional Information:
Publications:
Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00096031     History of Changes
Other Study ID Numbers: CDR0000391201, S0415, U10CA032102
Study First Received: November 9, 2004
Results First Received: April 4, 2012
Last Updated: April 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the esophagus
recurrent esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014