Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

Temple University Health System (TUHS)

Status and phase: Terminated; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: cetuximab; Drug: Capecitabine; Drug: bevacizumab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00321100

FER-GI-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

Active Comparator group

Description:

Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

Treatment:

Drug: Oxaliplatin

Drug: bevacizumab

Drug: Capecitabine

Drug: cetuximab

Cetuximab, Oxaliplatin, Capecitabine

Active Comparator group

Description:

Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Treatment:

Drug: cetuximab