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Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Outcome Description:

Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.

Outcome Time Frame:

17-19 weeks

Safety Issue:

No

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Desert Regional Medical Center Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000476577

NCT ID:

NCT00335959

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Gastric Cancer
  • adenocarcinoma of the stomach
  • stage I gastric cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • Stomach Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Medical City Dallas HospitalDallas, Texas  75230
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Mecosta County Medical CenterBig Rapids, Michigan  49307
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Shaw Regional Cancer CenterEdwards, Colorado  81632