ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer

Phase 1

Withdrawn

• Conditions: Lip and Oral Cavity Cancer; Head and Neck Cancer; Oropharyngeal Cancer

• Registration Number: NCT00006106
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

RATIONALE: A specially modified virus called ONYX-015 may be able to kill tumor cells while leaving normal cells undamaged. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ONYX-015 with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and fluorouracil in treating patients who have advanced head and neck cancer.

Detailed Description

OBJECTIVES:

I. Determine the feasibility and maximum tolerated dose (MTD) of intraarterial ONYX-015 in patients with advanced squamous cell cancer of the head and neck.

II. Determine the feasibility and tolerability of intraarterial ONYX-015 at the MTD OR maximum theraputic dose, whichever is lower, in combination with intravenous cisplatin and fluorouracil in these patients.

III. Determine the qualitative distribution of ONYX-015 within a limited tumor biopsy and a normal mucosal biopsy at different dose levels.

IV. Determine the response of these patients to intraarterial ONYX-015. V. Determine the response of these patients to cisplatin and fluorouracil following intraarterial ONYX-015.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intraarterial infusions of ONYX-015. Treatment repeats once in 3-4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-8 patients receive escalating doses of ONYX-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicity.

Patients in cohorts 1-4 are followed for 5 days after infusion, weekly for 3 weeks, at week 6, and monthly thereafter for 4 months.

A fifth or final cohort of 10 patients will receive ONYX-015 at the MTD. If the MTD was not determined in cohorts 1-4, patients receive the highest dose administered to cohort 4. Beginning 1-2 days after ONYX-015 infusion, patients receive cisplatin IV over 30-60 minutes once and fluorouracil IV continuously over 4 days. Treatment repeats in 4 weeks in the absence of disease progression or unacceptable toxicity. Cisplatin and fluorouracil IV treatment continues every 3-4 weeks at the discretion of the treating oncologist.

Patients in cohort 5 are followed for 5 days after initial infusion, weekly for 4 weeks, at week 8, and monthly thereafter for 4 months.

PROJECTED ACCRUAL:

A total of 23-28 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2000-08-03
• Study First Submitted QC: 2004-04-28
• Study First Posted: 2004-04-29
• Status Verified: 2006-12
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States