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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222729
First received: September 16, 2005
Last updated: January 10, 2014
Last verified: January 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • To evaluate the time to progression (primary endpoint) with the combination of pemetrexed and bevacizumab in recurrent or metastatic head and neck cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the objective response rate, duration of response, overall survival, and toxicities associated with the above therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A secondary endpoint will be the objective response rate.A secondary endpoint will be the objective response rate. The target response rate for the combination is 40%, and if the target is in fact observed, its 95% confidence interval will be 30%. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222729

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222729     History of Changes
Other Study ID Numbers: 05-002, 12,158
Study First Received: September 16, 2005
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
head
neck

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

ClinicalTrials.gov processed this record on August 21, 2014