Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer

NCT00444678 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: NYU# 04-10 H11817CA225056
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.

Conditions

Colorectal Cancer; Neoplasm Metastasis

Keywords

Previously untreated metastatic colorectal cancer; Metastatic Colorectal Cancer; combined therapy; biologics therapy; antibody; chemotherapy; EGFR; epidermal growth factor receptor

Outcome Measures

Primary Outcomes (1)

• Response Rate for the Combination Treatment

  The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.

  6 months since the start of treatment

Secondary Outcomes (3)

• Toxicity Rates

  1 year since the first treatment and every year after for up to 10 years

• Time to Progression

  6 months since the start of treatment and every 3 months after treatment for up to 10 years

• Survival

  6 months since the start of treatment and every 3 months after treatment for up to 10 years

Study Arms (1)

Cetuximab, Capecitabine and Oxaliplatin

EXPERIMENTAL

Drug: Cetuximab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Cetuximab DRUG

500 mg/m2, IV every two weeks

Also known as: Erbitux, C225

Cetuximab, Capecitabine and Oxaliplatin

Oxaliplatin DRUG

85 mg/m2, IV, q 2 weeks

Also known as: Eloxatin

Cetuximab, Capecitabine and Oxaliplatin

Capecitabine DRUG

2500 mg, po bid x 7 days every two weeks

Also known as: Xeloda

Cetuximab, Capecitabine and Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Subjects must have signed an approved informed consent.
• Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis.
• No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant therapy with 5FU/LV or IFL (irinotecan, fluorouracilis, and leucovorin (folinic acid)) permitted if completed at least six months prior to entering this study.
• Measurable disease by RECIST criteria as defined in Section 3.3.1.
• Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing for EGFR expression.
• ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1.
• Recovery in full from any previous surgical procedure.
• Expected survival greater than 12 weeks.
• Subjects at least 18 years of age.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
• Adequate hematologic function defined by an absolute neutrophil count (ANC) \> 1,500/mm3, a platelet count \> 100,000/mm3 .
• Adequate hepatic function defined by a total bilirubin level no greater than 2.0 times the upper limit of normal (ULN) and AST (Aspartate Aminotransferase) and ALT (alanine transaminase) levels noo greater than 2.5 times the ULN (AST and ALT levels no greater than 5 times the ULN in the presence of liver metastases).
• Adequate renal function defined by a serum creatinine level no greater than 1.5 times the ULN.

You may not qualify if:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.
• Subjects with \> Grade 1 neuropathy.
• Any active or uncontrolled infection.
• History of myocardial infarction within the previous six months or current clinical evidence of congestive heart failure.
• History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
• Central nervous system metastases.
• Pregnant or lactating women. Men and women of reproductive potential must agree to use an effective contraceptive method.
• Medical or psychiatric disorders that would interfere with informed consent or make them a poor risk for participation in this trial.
• Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
• Subjects receiving a prior investigational agent within 30 days.
• Prior therapy with oxaliplatin, cetuximab, or prior therapy that targets the EGF ( epidermal growth factor) pathway.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Sponsors & Collaborators

• NYU Langone Health: lead
• Eli Lilly and Company: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; 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: Deirdre Cohen, MD
• Organization: NYU Langone Health

Deirdre.Cohen@nyulangone.org

212-731-5656

Study Officials

• Deirdre Cohen, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 8, 2007
• Study Start: June 1, 2004
• Primary Completion: August 1, 2012
• Study Completion: June 1, 2015
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-04

Locations

US (2)