Phase 2 N=83 Treatment

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

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00686166 ↗

Enrolled (actual)

Serious AEs

0.5%

Results posted

Feb 2016

Primary outcome: Primary: Pathologic Complete Response Rate — 25 percentage of participants — p=0.18

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cetuximab (Biological); capecitabine (Drug); oxaliplatin (Drug); therapeutic surgical procedure (Procedure); radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pathologic Complete Response Rate	25	0.18
SECONDARY 3-year Disease-free Survival	68	—
SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.	15; 11; 3; 15; 12; 2	—

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. 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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00686166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.