Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer

NCT00238147 | Completed Phase 1

• 7 other identifiers: 6227UWCC-UW-6227AVENTIS-UW-03031ROCHE-UW-03031UW-03031UWCC-04-2311-D-01CDR0000445238
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination 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 trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.

Conditions

Esophageal Cancer

Keywords

stage II esophageal cancer; stage III esophageal cancer

Interventions

capecitabine DRUG

carboplatin DRUG

docetaxel 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 esophageal or gastroesophageal junction cancer * Locally advanced disease, meeting 1 of the following staging criteria: * T3, N0, M0 disease * Any T, N1, M0 disease * Measurable or evaluable disease PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST/ALT normal Renal * Creatinine ≤ 2.0 mg/dL * Creatinine clearance ≥ 80 mL/min Cardiovascular * No uncontrolled congestive heart failure * No symptomatic coronary artery disease * No uncontrolled arrhythmias * No myocardial infarction within the past 12 months * No other uncontrolled clinically significant cardiac disease Gastrointestinal * Able to swallow tablets * Intact upper gastrointestinal tract * No malabsorption syndrome Immunologic * No history of unanticipated severe reaction to fluoropyrimidine * No known hypersensitivity to fluorouracil * No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No serious infection that requires continuous antibiotic therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No history of seizures * No history of serious psychiatric illness that would preclude study compliance or giving informed consent * No peripheral neuropathy \> grade 1 PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Radiotherapy * No prior radiotherapy Other * More than 28 days since prior investigational drugs * No concurrent warfarin for active anticoagulation

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Rao S, Oelschlager BK, Koh WJ, et al.: Phase I trial with weekly docetaxel, capecitabine and carboplatin followed by concomitant capecitabine and radiotherapy in patients with locally advanced esophageal cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-123, 2008.

  RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Capecitabine; Carboplatin; Docetaxel; 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

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; Combined Modality Therapy; Therapeutics

Study Officials

• Sujata Rao, MD

  Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: September 1, 2004
• Study Completion: August 1, 2008
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

US (2)