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

December 30, 2021 updated by: Fox Chase Cancer Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: bevacizumab
Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
Other Names:
  • Avastin
Drug: cetuximab
Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle
Other Names:
  • Erbitux
Drug: Oxaliplatin
Oxaliplatin 130mg/m2 IV day 1 every 21 days
Other Names:
  • Eloxatin
Drug: Capecitabine
Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Other Names:
  • Xeloda
Active Comparator: 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
Drug: cetuximab
Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19)

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):

  1. complete response (CR): Disappearance of all lesions
  2. partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL
  3. stable disease (SD): Neither PR, PD, or CR
  4. progressive disease (PD): >=20% increase in the SoL; from smallest SoL. Or appearance of new lesion
  5. early death from malignant disease
  6. early death from toxicity
  7. 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: every 6-9 weeks; from dose of first study drug to event

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
Overall Survival
Time Frame: From dose of first study drug to last timepoint known to be alive (median follow-up for all patients was 25.9 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 12, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

December 18, 2013

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER-GI-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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