Study of Pemetrexed and Bevacizumab in Patients With Head and Neck Cancer

NCT00222729 | Completed Phase 2 Results DMC

• 2 other identifiers: 05-00212,158
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.

Conditions

Cancer

Keywords

head; neck

Outcome Measures

Primary Outcomes (1)

• Time-to-progression (TTP)

  TTP was calculated from treatment initiation to disease progression or last follow-up.

  Up to 36 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (1)

Pemetrexed & Bevacizumab

EXPERIMENTAL

Drug: Pemetrexed; Drug: Bevacizumab

Interventions

Pemetrexed DRUG

500 mg/m2 day 1 q 21 days

Also known as: (N-[4-[2-(2-amino-3,4-dihydron-4-oxo-7H-pyrolo[2,3-d]pyrinidin-5-yl)ethyl]benzoyl]-L-glutamic acid), Alimta, pemetrexed disodium, LY231514, MTA

Pemetrexed & Bevacizumab

Bevacizumab DRUG

15 mg/kg IV q 21 days following pemetrexed

Also known as: NSC 704865, RhuMAb VEGF, Bevacizumab, Avastin

Pemetrexed & Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with local recurrence will be considered incurable by means of locoregional therapy, as judged by the investigator.
• Cytologically or histologically confirmed squamous cell carcinoma. Nasopharyngeal carcinoma of histologic subtype WHO II and III will be excluded.
• Unidimensional measurable disease (RECIST criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
• ECOG performance status 0-1.
• Full recovered from the effects of any prior surgery, or radiation therapy. A minimum time period of 3 weeks will elapse between the completion of extensive radiation therapy for recurrent/metastatic disease and enrollment in the study
• Laboratory values:
• ANC ³ 1500/mm³. Platelets ³ 100,000/mm³. Total Bilirubin within normal institutional limits.
• Transaminases (AST and ALT) \< 3 x ULN. Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula.
• Urine protein to creatinine (UPC) ratio of ≤ 1.0 on spot urine urinalysis.
• Age \> 18 years and capacity to give informed consent.

You may not qualify if:

• Prior chemotherapy or biologic therapy for recurrent/metastatic head and neck cancer.
• Prior pemetrexed, bevacizumab, or other antiangiogenesis agents at any time.
• Presence of tumors that invaded major vessels.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration. Serious non-healing wound, ulcer, or bone fracture.
• History of brain metastasis or seizures.
• Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 5-year disease-free interval.
• Pre-existing peripheral neuropathy \> grade 2.
• Myocardial infarction or stroke in the last 6 months. Unstable angina; Heart Association (NYHA) Grade II or greater congestive heart failure; Clinically significant peripheral vascular disease; CNS cerebrovascular ischemia within the last 6 months; active serious infection; other coexisting medical condition that would preclude full compliance with the study
• Bleeding diathesis or coagulopathy.
• Therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed) or INR greater than 1.5 at registration
• History of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more).
• Uncontrolled hypertension (\>150/100)
• Pregnant or lactating.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eli Lilly and Company: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15216, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Pemetrexed; Bevacizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Rita Johnson, Associate Director of Clinical Research Services
• Organization: UPMC Cancer Centers

johnsonr1@upmc.edu

412-647-8571

Study Officials

• Julie Bauman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 16, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)