Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

NCT00290719 | Terminated Phase 1 DMC

• 3 other identifiers: CDR0000456200UCSF-034510ZENECA-1839US/0244
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, 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. Giving gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathological response (complete and partial) post-operatively

Secondary Outcomes (5)

• Safety and toxicity post-operatively

• Response rate 2 weeks into treatment, pre-operatively, and post-operatively

• Completeness of resection post-operatively

• Surgical morbidity and mortality post-operatively

• Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment

Interventions

cisplatin DRUG

gefitinib DRUG

irinotecan hydrochloride DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus * AC of the gastroesophageal junction allowed * Tumor must be considered surgically resectable (T1-3, NX) * No early-stage cancer (T1, N0) * The following lymph node (LN) criteria are considered acceptable: * Regional thoracic LN metastases (N1) * LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan * Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan * No distant metastases (M0) PATIENT CHARACTERISTICS: * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Creatinine clearance ≥ 50 mL/min * Creatinine serum level ≤ CTC grade 2 * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST \< 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No known severe hypersensitivity to gefitinib or any of its excipients * No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease * No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina * No New York Heart Association class III or IV heart disease * No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix * No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation * No evidence of any significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for esophageal cancer * No prior radiotherapy that would overlap the study treatment fields * Recovered from prior major surgery * No nonapproved or investigational drugs within the past 30 days * No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Gefitinib; Irinotecan; 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)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Combined Modality Therapy; Therapeutics

Study Officials

• Andrew Ko, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

US (1)