Status:
TERMINATED
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
Lead Sponsor:
George Albert Fisher
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Rectal Cancer
Colo-rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The objectives of this study are to: 1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 2. To determine...
Detailed Description
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Histologically-confirmed adenocarcinoma of the rectum. Clinical stages T3; T4; or N1 as determined by endoscopic ultrasound; or a rectal CT or MRI scan are eligible, including T3 N0; T3 N1; T4 N0; T4 N1; T1-4 N1. Rectal cancers are defined as those whose distal border extends to within 12 cm of the anal verge.
- Age ≥ 18
- Karnofsky performance status (KPS) ≥ 70
- Leukocyte count \> 3,500 x 10e6/µL
- Platelet count \> 100,000/µL
- Serum glutamic-oxaloacetic transaminase (SGOT) \< 2.5 x institutional upper limits of normal (ULN)
- Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x ULN
- Alkaline phosphatase \< 2.5 x ULN
- Total bilirubin \< 1.5x ULN
- Creatinine:
- Within normal institutional limits
- OR
- Creatinine clearance \> 60 mL/min/1.73 m2 (if serum creatinine levels above institutional normal)
- Ability to swallow pills without difficulty
- Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study medication
- Women of child-bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the treatment
- EXCLUSION CRITERIA
- Metastatic (M1) or stage IV disease
- Prior history of treatment with cetuximab or other therapy targeting EGFR
- Prior history of anti-cancer murine monoclonal antibody therapy
- Prior pelvic or whole abdominal radiotherapy
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness / social situations that would limit compliance with study requirements
- Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study (EXCEPTION: concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix may be allowed at the investigator's discretion)
- Inability to sign written consent
- Pregnant or breastfeeding
- Unwilling or unable to use effective contraception in self or partner for the entire study period and for up to 4 weeks after the study
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00226941
Start Date
June 1 2004
End Date
February 1 2009
Last Update
December 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine
Stanford, California, United States, 94305