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A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

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Trial Conditions
  • Esophageal Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18  - 74 

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed primary squamous cell or adenocarcinoma* of the esophagus or
gastroesophageal junction

- Patients with involvement of the gastroesophageal junction with Siewert type I
or II tumors (tumors arising from the distal esophagus and involving the
esophagogastric junction or tumors starting at the esophagogastric junction and
involving the cardia) are eligible

- Patients with cervical esophageal carcinoma are eligible

- Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy
are eligible NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on
history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or
chest/abdominal CT scan within 6 weeks prior to registration

- Disease must be encompassed in a radiotherapy field

- No evidence of tracheoesophageal fistulas or invasion into the trachea or major
bronchi

- Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo
bronchoscopy to exclude fistula

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,500/mm³

- Platelets ≥ 100,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL
allowed)

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 3 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Total intake (oral/enteral) must be ≥ 1,500 kCal/day

- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the breast, oral cavity, or cervix) unless disease-free for ≥ 2 years

- No prior allergic reaction to the study drugs

- No prior severe infusion reaction to a monoclonal antibody

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 3 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Acquired immune deficiency syndrome based upon current CDC definition

- HIV testing is not required for entry into this study

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another
cancer allowed)

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior platinum-based and/or paclitaxel-based therapy

- No prior radiotherapy that would result in overlap of planned study radiotherapy
fields

- No concurrent investigational agent

- No concurrent cytotoxic agent

- No other concurrent radiotherapy

Gender: Both
Steward Physician(s)
  • Mohan Suntharalingam, MD
  • David H. Ilson, MD, PhD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Biological
  • cetuximab
Drug
  • cisplatin
  • paclitaxel
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Mohan Suntharalingam, MD
  • David H. Ilson, MD, PhD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00655876
Volunteers:  Not Accepting Healthy Volunteers

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