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

NCT00321100 | Terminated Phase 2 Results DMC

• 1 other identifier: FER-GI-002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

metastatic; colorectal; cancer; initial therapy

Outcome Measures

Primary Outcomes (1)

• 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): 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 Outcomes (2)

• Time to Progression (TTP)

  every 6-9 weeks; from dose of first study drug to event

• Overall Survival

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

Study Arms (2)

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

ACTIVE COMPARATOR

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; Drug: cetuximab; Drug: Oxaliplatin; Drug: Capecitabine

Cetuximab, Oxaliplatin, Capecitabine

ACTIVE COMPARATOR

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

Interventions

bevacizumab DRUG

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

Also known as: Avastin

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

cetuximab DRUG

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

Also known as: Erbitux

Cetuximab, Oxaliplatin, Capecitabine; Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

Oxaliplatin DRUG

Oxaliplatin 130mg/m2 IV day 1 every 21 days

Also known as: Eloxatin

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

Capecitabine DRUG

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

Also known as: Xeloda

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related 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. A Fox Chase extramural research study. J Gastrointest Cancer. 2012 Dec;43(4):562-9. doi: 10.1007/s12029-012-9368-3.

  PMID: 22294255 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Bevacizumab; Cetuximab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Steven Cohen
• Organization: Fox Chase Cancer Center

steven.cohen@fccc.edu

215-214-1676

Study Officials

• Steven Cohen, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: April 12, 2006
• Primary Completion: April 1, 2009
• Study Completion: December 18, 2013
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2021-12

Locations

US (1)