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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222729
First Posted: September 22, 2005
Last Update Posted: February 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Cancer Drug: Pemetrexed Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Time-to-progression (TTP) [ Time Frame: Up to 36 months ]
    TTP was calculated from treatment initiation to disease progression or last follow-up.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 36 months ]
  • Overall Survival (OS) [ Time Frame: Up to 36 months ]

Enrollment: 42
Study Start Date: November 2005
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed & Bevacizumab Drug: Pemetrexed
500 mg/m2 day 1 q 21 days
Other Name: (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
Drug: Bevacizumab
15 mg/kg IV q 21 days following pemetrexed
Other Name: NSC 704865, RhuMAb VEGF, Bevacizumab, Avastin

Detailed Description:
Main objectives of this study are to 1) evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer; 2) evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy and 3) collect tumor tissue from previous diagnostic procedures and blood specimens prospectively, before and after therapy, for future correlative studies.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Cytologically or histologically confirmed squamous cell carcinoma. Nasopharyngeal carcinoma of histologic subtype WHO II and III will be excluded.
  3. 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.
  4. ECOG performance status 0-1.
  5. 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
  6. Laboratory values:

    ANC ³ 1500/mm³. Platelets ³ 100,000/mm³. Total Bilirubin within normal institutional limits.

  7. Transaminases (AST and ALT) < 3 x ULN. Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula.
  8. Urine protein to creatinine (UPC) ratio of ≤ 1.0 on spot urine urinalysis.
  9. Age > 18 years and capacity to give informed consent.

Exclusion Criteria:

  1. Prior chemotherapy or biologic therapy for recurrent/metastatic head and neck cancer.
  2. Prior pemetrexed, bevacizumab, or other antiangiogenesis agents at any time.
  3. Presence of tumors that invaded major vessels.
  4. 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
  5. Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment.
  6. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration. Serious non-healing wound, ulcer, or bone fracture.
  7. History of brain metastasis or seizures.
  8. 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.
  9. Pre-existing peripheral neuropathy > grade 2.
  10. 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
  11. Bleeding diathesis or coagulopathy.
  12. Therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed) or INR greater than 1.5 at registration
  13. History of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more).
  14. Uncontrolled hypertension (>150/100)
  15. Pregnant or lactating.
  16. Use of NSAIDs within 5 days of protocol therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222729


Locations
United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15216
Sponsors and Collaborators
University of Pittsburgh
Eli Lilly and Company
Genentech, Inc.
Investigators
Principal Investigator: Julie Bauman, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222729     History of Changes
Other Study ID Numbers: 05-002
12,158
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: January 15, 2016
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016

Keywords provided by University of Pittsburgh:
head
neck

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Bevacizumab
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors