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

Colorectal Neoplasms Clinical Trial

Official title:

Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00321100
• Other study ID #: FER-GI-002
• Status: Terminated
• Phase: Phase 2
• Start date: April 12, 2006
• Est. completion date: December 18, 2013

Study information

• Verified date: December 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 18, 2013
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression): complete response (CR): Disappearance of all lesions; partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL; stable disease (SD): Neither PR, PD, or CR; progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion; early death from malignant disease; early death from toxicity; early death from other cause; 9) unknown (not assessable, insufficient data)	every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)
Secondary	Time to Progression (TTP)	Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan: Complete response (CR): Disappearance of all lesions Partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion	every 6-9 weeks; from dose of first study drug to event
Secondary	Overall Survival	Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration	From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months)