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

NCT00711412 | Completed Phase 2 Results DMC

• 2 other identifiers: NU 05I2STU00006779
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Determine Pathologic Complete Response

  Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer

  At time of surgery

Secondary Outcomes (6)

• Clinical Response Rate

  four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery

• Recurrence Rate

  From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.

• Time to Progression

  From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.

• Patterns of Failure

  At time of surgery

• Toxicity Profile

  During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.

Study Arms (1)

Induction, Combination and surgery

EXPERIMENTAL

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

Drug: Induction Therapy - Capecitabine; Drug: Induction Therapy - Oxaliplatin; Drug: Combination Therapy - Capecitabine; Drug: Combination Therapy - Oxaliplatin; Radiation: Combination Therapy - Radiation; Procedure: Evaluation for response and surgery

Interventions

Induction Therapy - Capecitabine 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, Combination and surgery

Induction Therapy - Oxaliplatin 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.

Induction, Combination and surgery

Combination Therapy - Capecitabine 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.

Induction, Combination and surgery

Combination Therapy - Oxaliplatin 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.

Induction, Combination and surgery

Combination Therapy - Radiation RADIATION

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

Induction, Combination and surgery

Evaluation for response and surgery PROCEDURE

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

Induction, Combination and surgery

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Dr. Mary Mulcahy
• Organization: Northwestern University

Mary.Mulcahy@nm.org

312 695 6182

Study Officials

• Mary Mulcahy, MD

  Robert H. Lurie Cancer Center

  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: July 5, 2008
• First Posted: July 8, 2008
• Study Start: May 31, 2006
• Primary Completion: May 29, 2009
• Study Completion: January 30, 2013
• Last Updated: July 18, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-07

Locations

US (1)