Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer

NCT00470184 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000543376RPCI-I-64105
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal 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 (1)

• Complete Response

  5.5 weeks

Secondary Outcomes (3)

• Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1

  5.5 weeks

• Median Time to Progression

  5.5 weeks

• Quality of Life Improved Rate

  5.5 weeks

Study Arms (1)

Chemo

EXPERIMENTAL

Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy

Drug: capecitabine; Drug: oxaliplatin; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: reverse transcriptase-polymerase chain reaction; Procedure: adjuvant therapy; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy

Interventions

capecitabine DRUG

Oral

Chemo

oxaliplatin DRUG

IV

Chemo

gene expression analysis GENETIC

Correlative Study

Chemo

microarray analysis GENETIC

Correlative Study

Chemo

reverse transcriptase-polymerase chain reaction GENETIC

Correlative Study

Chemo

adjuvant therapy PROCEDURE

Metastatic growth control

Chemo

biopsy PROCEDURE

Examination of tissue type

Chemo

conventional surgery PROCEDURE

Tissue removal

Chemo

neoadjuvant therapy PROCEDURE

Tumor shrinkage

Chemo

quality-of-life assessment PROCEDURE

Correlative Study

Chemo

radiation therapy RADIATION

Undergoing radiation therapy

Chemo

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus * Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound * Bulk of gastroesophageal junction tumor should be in the esophagus * Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 4 months * WBC \> 4,000/mm³ * ANC \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 9 g/dL * Bilirubin normal * Creatinine normal * AST \< 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Able to take oral medication or undergo enteral administration of medication * No peripheral neuropathy ≥ grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 90 days after completion of study treatment * No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy * No concurrent uncontrolled illness, including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would preclude study compliance * No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * Other cured tumors allowed at discretion of the principal investigator * No known HIV or hepatitis B or C (active and/or previously treated) PRIOR CONCURRENT THERAPY: * No prior therapy for esophageal cancer * No other concurrent investigational agents

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
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Capecitabine; Oxaliplatin; Gene Expression Profiling; Microarray Analysis; Reverse Transcriptase Polymerase Chain Reaction; Chemotherapy, Adjuvant; Biopsy; 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)

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; Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Nikhil Khushalani, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2012
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

US (1)