Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer

NCT00258323 | Completed Phase 2 DMC

• 4 other identifiers: CCF5848P30CA043703CCF-5848ZENECA-1839/US/0233
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Survival at 1 year

  Survival at 1 year

  1 year

• Distant metastatic control at 1 year

  Distant metastatic control at 1 year

  1 year

Secondary Outcomes (3)

• Response rate at 6 weeks

  6 weeks

• Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks

  6 weeks

• Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy

  8 weeks

Interventions

cisplatin DRUG

20mg/m2d/IV continuous infusion x days

Also known as: CDDP

fluorouracil DRUG

1000mg/m2/d IV continuous infusion x 4 days

Also known as: 5 FU

Iressa DRUG

250mg po qd days 1-28 then x 2 years

Also known as: ZD 1839

conventional surgery PROCEDURE

conventional surgery

radiation therapy RADIATION

150 cGy bid

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction * T3, N1, or M1a disease only * The following types are not allowed: * Small cell undifferentiated carcinomas, lymphomas, or sarcomas * Small cell or mixed small cell/non-small cell histology * No evidence of distant hematogenous tumor metastases (M1b) * No malignant pleural effusions PATIENT CHARACTERISTICS: Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC \> 3,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Alkaline phosphatase \< 2 times normal * AST \< 2 times normal * No unstable or uncompensated hepatic disease Renal * Creatinine ≤ 2.0 mg/dL * Calcium normal * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncontrolled angina * No unstable or uncompensated cardiac disease Pulmonary * See Disease Characteristics * No limitations to pulmonary function that would preclude study participation * No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed) * No unstable or uncompensated respiratory disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No evidence of severe or uncontrolled systemic disease * No other uncontrolled malignancy * No active infection * No known severe hypersensitivity to gefitinib or any of its excipients PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for this cancer Chemotherapy * No prior chemotherapy for this cancer Radiotherapy * No prior radiotherapy for this cancer Surgery * Recovered from any prior oncologic or other major surgery * No prior surgical resection for this cancer * No concurrent ophthalmic surgery Other * No prior photodynamic therapy for this cancer (prior laser treatments are acceptable) * More than 30 days since prior unapproved or investigational drug * 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

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Fluorouracil; Gefitinib; 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; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• David J. Adelstein, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: February 1, 2010
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

US (1)