Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery

NCT00448760 | Completed Phase 2 Results

• 3 other identifiers: 20040006SCCC-2003151WIRB-20051464
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, 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. Giving chemotherapy 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 combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.

Conditions

Esophageal Cancer

Keywords

stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.

  8 - 16 weeks

Secondary Outcomes (3)

• Clinical Response

  8 - 16 weeks

• Median Progression-free Survival (PFS)

  24 months

• Overall Survival

  24 months

Study Arms (1)

Neoadjuvant + Adjuvant Chemotherapy

EXPERIMENTAL

Drug: Docetaxel; Drug: Floxuridine; Drug: Leucovorin; Drug: Oxaliplatin; Genetic: Microarray analysis; Genetic: reverse transcriptase-polymerase chain reaction; Procedure: Conventional surgery

Interventions

Docetaxel DRUG

Intravenously, 25 mg/m2, over 30 minutes, 2 cycles

Also known as: Taxotere

Neoadjuvant + Adjuvant Chemotherapy

Floxuridine DRUG

Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles

Also known as: FUdR

Neoadjuvant + Adjuvant Chemotherapy

Leucovorin DRUG

Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles

Neoadjuvant + Adjuvant Chemotherapy

Oxaliplatin DRUG

Intravenously, 85 mg/m2, over 2 hours, 2 cycles

Neoadjuvant + Adjuvant Chemotherapy

Microarray analysis GENETIC

Analysis of tumor for pathologic response to protocol therapy

Neoadjuvant + Adjuvant Chemotherapy

reverse transcriptase-polymerase chain reaction GENETIC

Analysis of tumor for pathologic response to protocol therapy

Neoadjuvant + Adjuvant Chemotherapy

Conventional surgery PROCEDURE

Surgical removal of tumor for correlative studies

Neoadjuvant + Adjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the esophagus meeting the following criteria: * Stage II or III disease * Resectable disease * Previously untreated disease * No stage I (mucosal only) or stage IV (metastatic) disease PATIENT CHARACTERISTICS: * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin \< 2 times normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must have central venous access * No other malignancy within the past 5 years * No concurrent medical or psychiatric problem that would preclude study treatment * No contraindications to paclitaxel PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy to the esophagus * No oral cryotherapy (e.g., ice chips) on day 1 of each course

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Solomon N, Mezentsev D, Reis I, Lima M, Rios J, Avisar E, Franceschi D, Livingstone A, Podolsky L, Ardalan B. A phase II study of neoadjuvant and adjuvant chemotherapy with 5-fluorodeoxyuridine, leucovorin, oxaliplatin and docetaxel in the treatment of previously untreated advanced esophageal adenocarcinoma. Jpn J Clin Oncol. 2011 Apr;41(4):469-76. doi: 10.1093/jjco/hyq239. Epub 2011 Jan 21.

  PMID: 21258083 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Docetaxel; Floxuridine; Leucovorin; Oxaliplatin; Microarray Analysis; Reverse Transcriptase Polymerase Chain Reaction

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Microchip Analytical Procedures; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques

Results Point of Contact

• Title: Bach Ardalan MD, Professor
• Organization: UM/Sylvester Comprehensive Cancer Center

bardalan@med.miami.edu

305-243-4909

Study Officials

• Bach Ardalan, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

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: March 15, 2007
• First Posted: March 19, 2007
• Study Start: October 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 7, 2017
• Results First Posted: February 18, 2013

Record last verified: 2016-12

Locations

US (1)