Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

NCT00281788 | Completed Phase 1

• 3 other identifiers: 4950DUMC-4950-05-8R2CDR0000449942
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel, 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 chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer.

Conditions

Esophageal Cancer

Keywords

stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer

Interventions

capecitabine DRUG

carboplatin DRUG

paclitaxel DRUG

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 carcinoma of the thoracic esophagus or gastroesophageal junction for which bimodality treatment with chemotherapy and radiotherapy is indicated * No tumors that extend above the level of the thoracic inlet or beyond 4 cm below the gastroesophageal junction * No esophageal perforation based on radiographic or bronchoscopic evidence * No known brain metastases, lymphangitic lung metastases, or carcinomatous meningitis PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 70% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * AST or ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 times ULN * Calcium ≤ 1.3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection or other serious underlying medical condition that would preclude study treatment * No dementia or significantly altered mental status that would preclude understanding or giving informed consent PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No other concurrent investigational therapy

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Capecitabine; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Herbert I. Hurwitz, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: September 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 21, 2013

Record last verified: 2008-04

Locations

US (1)