Oxaliplatin, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer

NCT00093652 | Terminated Phase 1

• 3 other identifiers: I 04603RPCI-I-04603ZENECA-IRUSIRES0303
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic esophageal cancer.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; recurrent esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; squamous cell carcinoma of the esophagus

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (phase I)

• Response (phase II)

Secondary Outcomes (4)

• Survival

• Quality of life

• Safety and toxicity

• Immunohistochemistry

Interventions

gefitinib DRUG

oxaliplatin DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction * Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound * Stage T2, N0 disease and beyond * Bulk of tumor must be in the esophagus of patients with GE junction tumor * Bronchoscopy is required if primary esophageal tumor is \< 26 cm from the incisors * No brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-1 Life expectancy * At least 4 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Granulocyte count ≥ 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin normal * ALT and AST ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN Renal * Not specified Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary * No clinically active interstitial lung disease * Patients with chronic stable asymptomatic radiographic changes are eligible Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation * No peripheral neuropathy ≥ grade II * No severe hypersensitivity to gefitinib or any of its excipients * No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy * No active or ongoing infection * No other uncontrolled illness * No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent colony-stimulating factors during course 1 of study therapy Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * Concurrent steroid therapy allowed Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 30 days since prior non-approved or investigational drugs * No concurrent administration of any of the following: * Phenytoin * Carbamazepine * Rifampin * Barbiturates * Highly-active antiretroviral therapy (HAART) * Hypericum perforatum (St. John's wort) * No other concurrent investigational agents or therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• Javle M, Pande A, Iyer R, Yang G, LeVea C, Wilding G, Black J, Nava H, Nwogu C. Pilot study of gefitinib, oxaliplatin, and radiotherapy for esophageal adenocarcinoma: tissue effect predicts clinical response. Am J Clin Oncol. 2008 Aug;31(4):329-34. doi: 10.1097/COC.0b013e318161dc04.

  PMID: 18845990 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Gefitinib; Oxaliplatin; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• Milind Javle, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: May 1, 2003
• Primary Completion: May 1, 2006
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (1)