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

NCT ID: NCT00321100

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-12
• Study Completion Date: 2013-12-18

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

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

Group Type: ACTIVE_COMPARATOR

bevacizumab

Intervention Type: DRUG

Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

cetuximab

Intervention Type: DRUG

Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 130mg/m2 IV day 1 every 21 days

Capecitabine

Intervention Type: DRUG

Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Cetuximab, Oxaliplatin, Capecitabine

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

Group Type: ACTIVE_COMPARATOR

cetuximab

Intervention Type: DRUG

Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle

Interventions

bevacizumab

Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

Intervention Type: DRUG

cetuximab

Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 IV day 1 every 21 days

Intervention Type: DRUG

Capecitabine

Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Intervention Type: DRUG

Other Intervention Names

Avastin; Erbitux; Eloxatin; Xeloda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22294255 (View on PubMed)

Other Identifiers

FER-GI-002

Identifier Type: -

Identifier Source: org_study_id