Clinical trial NCT00321100: Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Official title: Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: metastatic
colorectal
cancer
initial therapy
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Detailed description: Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.

Eligibility criteria: Inclusion Criteria:

* measurable metastatic adenocarcinoma of the colon or rectum
* no prior systemic therapy for metastatic disease
* adjuvant therapy must have been completed \>/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed \> 6 months prior to study entry
* must have tumor tissue available for EGFR and thymidine phosphorylase evaluation
* ECOG PS 0-1
* age \>/= 18
* adequate organ function: WBC\>/=3,000, ANC \>/=1,500, platelets\>/= 100,000, total bilirubin \</= 1.5X ULN, AST\&ALT \</= 2.5X ULN, create clearance \>/= 50mL/min
* negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
* ability to understand and willing to sign written ICF
* able to swallow and absorb oral medication

Exclusion Criteria:

* medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing)
* history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
* surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
* urine protein:creatinine ration \>/=1.0 at screening
* evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
* prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin
* underlying neuropathy \>/= grade 2
* TIA or CVA w/in 6 months

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: every 6-9 weeks; from dose of first study drug to event
measure: Overall Survival
timeFrame: From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A phase II study of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as frontline therapy for metastatic colorectal cancer. A Fox Chase extramural research study. J Gastrointest Cancer. 2012 Dec;43(4):562-9. doi: 10.1007/s12029-012-9368-3.