S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery

NCT ID: NCT00335959

Last Updated: 2012-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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 with stomach cancer that can be removed by surgery.

Detailed Description

OBJECTIVES:

• Determine the pathologic complete response rate in patients with primary gastric adenocarcinoma treated with neoadjuvant chemoradiotherapy comprising oxaliplatin, capecitabine, and radiotherapy. (This will not be completed as this study was closed early due to poor accrual.)
• Assess the frequency and severity of toxicities associated with this regimen.
• Explore, preliminarily, the association between DNA repair genes (ERCC-1, XRCC1, GST-P1, XPD, XPA, ribonucleotide reductase), target enzymes (thymidylate synthase [TS], dihydropyrimidine dehydrogenase, thymidine phosphorylase [TP]), and angiogenic factors (vascular endothelial growth factor [VEGF], epidermal growth factor [EGF], PD-ECGF, basic fibroblast growth factor, TSP-1 and -2, transforming growth factor [TGF]-β, and IL-8) and response to neoadjuvant therapy in patients with adenocarcinoma of the stomach. (This will not be completed as this study was closed early due to poor accrual.)
• Explore, preliminarily, the association of haplotypes of candidate genes of TS, TP, ERCC-1, XPD, GST-P1, cyclooxygenase-2, EGF receptor, TGF-β, VEGF, and IL-8 with response and toxicity to neoadjuvant chemoradiation therapy in these patients. (This will not be completed as this study was closed early due to poor accrual.)
• Explore, preliminarily, the feasibility of performing comparative genomic hybridization for analysis of DNA copy number changes in predicting response to neoadjuvant chemoradiation therapy. (This will not be completed as this study was closed early due to poor accrual.)

OUTLINE: This is a multicenter, pilot study.

• Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on days 1 and 22 and oral capecitabine twice daily on days 1-14 and 22-35 in the absence of disease progression or unacceptable toxicity.
• Neoadjuvant chemoradiotherapy: Patients receive oral capecitabine twice daily on days 43-77 and undergo radiotherapy once daily on days 43-47, 50-54, 57-61, 64-68, and 71-75 in the absence of disease progression or unacceptable toxicity.
• Surgery: Patients with stable or responding disease undergo surgery 4-6 weeks after completion of chemoradiotherapy.

Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions

Gastric Cancer

Keywords

adenocarcinoma of the stomach; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer

Study Design

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

Study Groups

Chemotherapy, Chemoradiation, Surgery

Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43.

Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.

oxaliplatin

Intervention Type: DRUG

130 mg/m2 by 2-hour infusion Days 1 and 22

conventional surgery

Intervention Type: PROCEDURE

Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

radiation therapy

Intervention Type: RADIATION

Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.

Interventions

capecitabine

850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.

Intervention Type: DRUG

oxaliplatin

130 mg/m2 by 2-hour infusion Days 1 and 22

Intervention Type: DRUG

conventional surgery

Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy

Intervention Type: PROCEDURE

radiation therapy

Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.

Intervention Type: RADIATION

Other Intervention Names

Xeloda (NSC-712807); Eloxatin (NSC-266046); gastrectomy; RT

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:

• Newly diagnosed disease amenable to curative resection
• Stage IB-III (T2-4)
• Measurable or nonmeasurable disease
• Enlarged lymph nodes outside of radiation fields must have preoperative biopsies

• No positive lymph nodes outside of radiation fields
• No distant metastasis
• No gastroesophageal junction tumors

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal
• Albumin ≥ 3 g/dL
• Bilirubin normal
• No evidence of ischemic heart disease by EKG
• No coronary artery disease requiring active medical treatment
• No symptoms of angina
• No history of myocardial infarction
• No deep vein thrombosis within the past 12 months
• No pre-existing peripheral neuropathy
• No active pneumonia or inflammatory lung infiltrate
• No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years
• No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no concurrent sorivudine or brivudine
• No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy
• No prior coronary angioplasty or stenting
• No concurrent 2-dimensional or intensity-modulated radiotherapy

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence P. Leichman, MD

Role: STUDY_CHAIR

Desert Regional Medical Center Comprehensive Cancer Center

Syed A. Ahmad, MD

Role: STUDY_CHAIR

Barrett Cancer Center

Locations

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, United States

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Shaw Regional Cancer Center

Edwards, Colorado, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Mecosta County Medical Center

Big Rapids, Michigan, United States

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

Metro Health Hospital

Grand Rapids, Michigan, United States

Holland Community Hospital

Holland, Michigan, United States

Hackley Hospital

Muskegon, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

St. John's Regional Health Center

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Billings Clinic - Downtown

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

St. James Healthcare Cancer Care

Butte, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

Great Falls, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Interlakes Oncology/Hematology PC

Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital

Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Samaritan North Cancer Care Center

Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Middletown Regional Hospital

Middletown, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Danville Regional Medical Center

Danville, Virginia, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Columbia Basin Hematology

Kennewick, Washington, United States

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Polyclinic First Hill

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Countries

United States

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0425

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000476577

Identifier Type: -

Identifier Source: org_study_id