Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

NCT ID: NCT00711412

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2013-01-30

Brief 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.

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction, Combination and surgery

Weeks 1-6:

Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8

Weeks 7-12:

Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday

Evaluation for response and resection surgery

Group Type: EXPERIMENTAL

Induction Therapy - Capecitabine

Intervention Type: DRUG

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.

Induction Therapy - Oxaliplatin

Intervention Type: DRUG

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.

Combination Therapy - Capecitabine

Intervention Type: DRUG

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.

Combination Therapy - Oxaliplatin

Intervention Type: DRUG

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.

Combination Therapy - Radiation

Intervention Type: RADIATION

1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

Evaluation for response and surgery

Intervention Type: PROCEDURE

Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.

Interventions

Induction Therapy - Capecitabine

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.

Intervention Type: DRUG

Induction Therapy - Oxaliplatin

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.

Intervention Type: DRUG

Combination Therapy - Capecitabine

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.

Intervention Type: DRUG

Combination Therapy - Oxaliplatin

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.

Intervention Type: DRUG

Combination Therapy - Radiation

1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.

Intervention Type: RADIATION

Evaluation for response and surgery

Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Mulcahy, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00006779

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05I2

Identifier Type: -

Identifier Source: org_study_id