ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
|First Received Date ICMJE||August 3, 2000|
|Last Updated Date||July 9, 2013|
|Start Date ICMJE||July 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006106 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer|
|Official Title ICMJE||Phase I Study of Intraarterial ONYX-015 in Combination With Intravenous Cisplatin and Fluorouracil in Patients With Advanced Squamous Cell Cancer of the Head and Neck|
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.
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.
A total of 23-28 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
|Ages||18 Years to 79 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00006106|
|Other Study ID Numbers ICMJE||DFCI-98320, CDR0000068117, NCI-G00-1832|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Dana-Farber Cancer Institute|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||December 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP