Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatments capecitabine - induction therapy, oxaliplatin - induction therapy, capcitabine - combination therapy, oxaliplatin - combination therapy, radiation - combination therapy
Phase phase 2
Sponsor Northwestern University
Start date October 2005
End date February 2018
Trial size 45 participants
Trial identifier NCT00711412, NU 05I2, STU00006779

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 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 II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Weeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
capecitabine - induction therapy
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
oxaliplatin - induction therapy
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
(Experimental)
Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
capcitabine - combination therapy
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
oxaliplatin - combination therapy
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
radiation - combination therapy
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

Primary Outcomes

Measure
Pathologic complete response
time frame: At time of surgery

Secondary Outcomes

Measure
Clinical response rate
time frame: Following chemotherapy treatment and prior to surgery
Recurrence rate
time frame: At the time of disease recurrence or death
Time to progression
time frame: At the time of progression of disease
Patterns of failure
time frame: At time of surgery
Toxicity profile
time frame: During chemotherapy and up to 30 days post-last dose of chemotherapy

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction - Stage I-IVA disease - No distant metastatic disease (other than regional lymph nodes) - No evidence of CNS metastases - CNS metastases stable for > 3 months allowed PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Consuming ≥ 1,500 calories daily - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT ≤ 2.5 times ULN - Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No pre-existing neuropathy - No prior unanticipated severe reaction to fluoropyrimidine therapy - No known hypersensitivity to fluorouracil - No known DPD deficiency - No known hypersensitivity to any of the components of oxaliplatin - No significant active infection or other severe complicated medical illness - No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) - No myocardial infarction within the past 12 months - No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake - No malabsorption syndrome - No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: - More than 4 weeks since prior participation in any investigational drug study - No prior pelvic or thoracic radiotherapy

Additional Information

Official title A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
Principal investigator Mary Mulcahy, MD
Description OBJECTIVES: Primary - Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy. Secondary - Determine the clinical response rate in patients treated with this regimen. - Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen. - Characterize the toxicity profile of this regimen in these patients. OUTLINE: - Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. - Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity. - Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy. After completion of study treatment, patients are followed every 3 months.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Northwestern University.