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

Cancer Clinical Trial

Official title:

Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222729
• Other study ID #: 05-002
• Secondary ID: 12,158
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 15, 2016
• Start date: November 2005
• Est. completion date: October 2013

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Pemetrexed
500 mg/m2 day 1 q 21 days
• Bevacizumab
15 mg/kg IV q 21 days following pemetrexed

Locations

Country	Name	City	State
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-progression (TTP)	TTP was calculated from treatment initiation to disease progression or last follow-up.	Up to 36 months	No
Secondary	Objective Response Rate (ORR)		Up to 36 months	No
Secondary	Disease Control Rate (DCR)		Up to 36 months	No
Secondary	Overall Survival (OS)		Up to 36 months	No