Safety and Efficacy Study Using Bevacizumab, Capecitabine and Oxaliplatin for Colorectal Cancer

NCT00177307 | Completed Phase 2 Results DMC

• 1 other identifier: 04-118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.

Conditions

Cancer

Keywords

colon; rectum

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  time from start of protocol therapy until objective tumor progression or death

  Up to 27 Months

Secondary Outcomes (3)

• Response Rate (RR)

  Up to 27 months

• Overall Survival

  Up to 40 months

• 1-, 2-, and 3-year Overall Survival

  Up to 40 months

Study Arms (1)

Oxaliplatin, Capecitabine, and Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Bevacizumab DRUG

Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity

Also known as: Capecitabine 2500 mg/m2/d in two divided doses, (May be 2000 or 3000 mg/m2/d after interim analysis) Days 1-8, every 2 weeks Until disease progression or unacceptable toxicity, Oxaliplatin 85 mg/m2 IV q 2 weekly Until disease progression, unacceptable toxicity,, or Grade 3 neuropathy or cumulative dose of 1200 mg/m2

Oxaliplatin, Capecitabine, and Bevacizumab

Capecitabine DRUG

Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).

Oxaliplatin, Capecitabine, and Bevacizumab

Oxaliplatin DRUG

Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine

Oxaliplatin, Capecitabine, and Bevacizumab

Eligibility Criteria

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

You may qualify if:

• advanced, surgically unresectable CRC
• measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension(histological confirmation of adenocarcinoma of the colon or rectum.
• ECOG performance status of 0, 1, or 2 Estimated life expectancy of at least 12 weeks.
• chemotherapy prior to the diagnosis of metastatic disease. The chemotherapy regimen must not have included oxaliplatin or bevacizumab. No prior therapy for metastatic disease is permitted.
• Evidence of adequate organ function, including:
• Evidence of adequate hepatic function,
• Evidence of adequate renal function INR \<1.5 x ULN (unless taking warfarin in which case it must be in the therapeutic range). Patients on warfarin are allowed to participate.
• Absence of proteinuria on urine analysis· Patients with a history of prior non-colorectal malignancies are eligible if they have been disease-free for at least 5 years prior to study entry and are deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Age \> 18 yrs.

You may not qualify if:

• Any systemic therapy administered for metastatic or locally recurrent disease. Patients who are considered candidates for surgical resection of metastatic and/or locally advanced disease.
• Any histology other than adenocarcinoma of the colon or rectum.
• Pregnancy or lactation at the time of patient entry or women of childbearing potential with no pregnancy test. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods during and for 6 months after study therapy.
• Serious concomitant medical conditions that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
• General Medical Concerns History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• Serious, uncontrolled, concurrent infection.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.
• Proteinuria at baseline or clinically significant impairment of renal function.
• Serious, non healing wound, ulcer, or bone fracture
• Subjects who can not take oral medication

Sponsors & Collaborators

• University of Pittsburgh: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nathan Bahary, MD
• Organization: University of Pittsburgh

baharyn@upmc.edu

412-864-7764

Study Officials

• Nathan Bahary, MD

  University of Pittsburgh

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, Division of Oncology

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Locations

US (1)