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Clinical Trials (PDQ®)

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 to 74NCI, OtherRTOG 0436
CDR0000538085, NCT00655876

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

  • To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery.

Secondary

  • To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients.
  • To evaluate adverse events in these patients.
  • To evaluate endoscopic complete response rates in these patients.
  • To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool.
  • To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (adenocarcinoma* vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.

NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

  • Arm I: Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo radiotherapy once daily, 5 days a week, for 5½ weeks for a total dose of 50.4Gy.
  • Arm II: Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo radiotherapy as in arm I.

Patients undergo endoscopy 6 to 8 weeks after completion of chemoradiotherapy. Quality of life is assessed at baseline, within 1 week of post-treatment endoscopy, and at 1 and 2 years from beginning of study treatment.

After completion of study treatment, patients are followed periodically.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Mohan SuntharalingamPrincipal Investigator

David H. IlsonStudy Chair

Trial Sites

U.S.A.
Florida
  Fort Lauderdale
 Broward General Medical Center Cancer Center
 Anurag Agarwal Ph: 954-941-8300
Georgia
  Gainesville
 Northeast Georgia Medical Center
 Frank G. Lake Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Paul A. DeMare Ph: 808-545-8548
 Hawaii Medical Center - East
 Paul A. DeMare Ph: 808-545-8548
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Indiana
  Indianapolis
 St. Vincent Oncology Center
 Robert H Liebross Ph: 317-338-2194
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Samir Narayan Ph: 734-712-3456
Nevada
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Daniel W Weed Ph: 775-982-4400
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
  Ravenna
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
Texas
  San Antonio
 University of Texas Health Science Center at San Antonio
 William E Jones Ph: 210-567-0653
  Email: che@uthscsa.edu
Virginia
  Alexandria
 INOVA Alexandria Hospital
 Jane Grayson Ph: 703-776-2580
  Email: research@inova.org
Washington
  Yakima
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
Wisconsin
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Email: Kelli.holton@wfhc.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00655876
ClinicalTrials.gov processed this data on March 31, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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