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S0713: Oxaliplatin, Capecitab...

S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

Last Updated: 2018-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2018-03-31

Brief Summary

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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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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 the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.

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Detailed Description

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OBJECTIVES:

* To assess the pathologic complete response rate for the combination of oxaliplatin, capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras.
* To estimate the 3-year disease-free survival probability in this patient population when treated with this regimen.
* To assess the frequency and severity of toxicities associated with this regimen in these patients.
* To explore, preliminarily, the association between expression levels of genes involved in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU pathway (i.e., k-ras, TS \[Thymidylate Synthase\], ERCC-1 \[excision repair cross complementing-1), TP \[Thymidine phosphorylase\], DPD \[Dihydropyrimidine dehydrogenase\], EGFR, VEGF \[vascular endothelial growth factor\], and IL-8 \[interleukin-8\]) and pathologic complete response. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)
* To explore, preliminarily, the intratumoral gene expression levels of these genes after completion of study treatment.(Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)
* To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation with clinical outcome and toxicity. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)

OUTLINE: This is a multicenter study.

* Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a week for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and cetuximab IV over 1-2 hours once a week for 5 weeks.
* Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later, patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5. Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo external beam radiotherapy 5 days a week for 5 weeks beginning in week 1.

Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 3-8 weeks after completion of chemoradiotherapy.

Blood samples are collected for germline polymorphism testing and tissue samples are collected and assessed for gene expression analysis.

After completion of study treatment, patients are followed every 6 months for 4 years.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo + Chemo and radiation + Surgery

Chemotherapy Cycle 1 (1 cycle is 35 days):

* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

Chemotherapy cycle 1: Cetuximab, 400 mg/m\^2, IV, Day 1; Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29

Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78

capecitabine

Intervention Type DRUG

Chemotherapy Cycle 1: Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)

oxaliplatin

Intervention Type DRUG

Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29

Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78

therapeutic surgical procedure

Intervention Type PROCEDURE

Surgical resection

radiation therapy

Intervention Type RADIATION

IMRT (intensity-modulated radiation therapy)

Interventions

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cetuximab

Chemotherapy cycle 1: Cetuximab, 400 mg/m\^2, IV, Day 1; Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29

Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78

Intervention Type BIOLOGICAL

capecitabine

Chemotherapy Cycle 1: Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)

Intervention Type DRUG

oxaliplatin

Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29

Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78

Intervention Type DRUG

therapeutic surgical procedure

Surgical resection

Intervention Type PROCEDURE

radiation therapy

IMRT (intensity-modulated radiation therapy)

Intervention Type RADIATION

Other Intervention Names

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IMG-C225 Erbitux NSC-714692 Xeloda NSC-712807 Eloxatin NSC-266046 Resection RT

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Biopsy-proven primary adenocarcinoma of the rectum

* Stage II or III disease
* The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination
* No recurrent disease
* Must have wild-type k-ras status
* Measurable and/or nonmeasurable disease

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-2
* Leukocyte count ≥ 3,000/mcL
* Granulocyte count ≥ 1,500/mcL
* Platelet count ≥ 100,000/mcL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN
* Creatinine clearance \> 50 mL/min
* No prior severe reaction to a monoclonal antibody
* Willing to have specimens submitted
* No peripheral neuropathy ≥ grade 2
* No known existing uncontrolled coagulopathy
* No evidence of current high-grade obstruction

* At least 2 weeks since prior diverting procedure
* No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment
* No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency
* No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine
* No uncontrolled intercurrent illness
* No ongoing or active infection
* No symptomatic congestive heart failure or unstable angina pectoris
* No cardiac arrhythmia or myocardial infarction within the past 12 months
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

* Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery)
* No prior chemotherapy, radiotherapy, or targeted therapy for this tumor
* More than 4 weeks since prior investigational agents
* No concurrent anti-retroviral therapy for HIV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia G. Leichman, MD

Role: STUDY_CHAIR

Breastlink

Locations

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Providence Cancer Center at Providence Hospital

Mobile, Alabama, United States

Site Status

Arizona Cancer Center at UMC Orange Grove

Tucson, Arizona, United States

Site Status

Arizona Cancer Center at University Medical Center North

Tucson, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Sutter Health - Western Division Cancer Research Group

Novato, California, United States

Site Status

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, United States

Site Status

Sutter Cancer Center at Roseville Medical Center

Roseville, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

California Pacific Medical Center - California Campus

San Francisco, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

Sutter Solano Medical Center

Vallejo, California, United States

Site Status

Memorial Hospital Cancer Center - Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Hays Medical Center

Hays, Kansas, United States

Site Status

Hutchinson Hospital Corporation

Hutchinson, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Kansas City Cancer Centers - West

Kansas City, Kansas, United States

Site Status

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Mount Carmel Regional Cancer Center

Pittsburg, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Site Status

Kansas City Cancer Center - Shawnee Mission

Shawnee Mission, Kansas, United States

Site Status

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States

Site Status