Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503997
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2007-07-17
Brief Title:
Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Phase II Trial Efficacy and Toxicity of Induction Pemetrexed ALIMTA and Oxaliplatin ELOXATIN in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving pemetrexed together with oxaliplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer
PURPOSE This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer
Detailed Description:
OBJECTIVES
Primary
To evaluate the clinical response rate in patients with locally advanced squamous cell carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and oxaliplatin
Secondary
To evaluate the pathological complete response in patients who undergo surgical resection or post-induction biopsy
To assess toxicity of therapy including the assessment of quality of life fatigue and head and neck cancer-related symptoms
To predict response and toxicities based on pharmacogenomics genomics and proteomics
OUTLINE This is a nonrandomized open-label study Patients are assigned to 1 of 2 groups based on resectability of disease resectable vs nonresectable
Group I resectable disease Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1 Treatment repeats every 14 days for up to 4 courses If patient progresses before receiving 4 courses of treatment treatment will be discontinued and patient will proceed to surgery
After completion of pemetrexed disodium and oxaliplatin patients undergo surgical resection of disease
Group II nonresectable disease Patients receive treatment as in group I If patient progresses before receiving 4 courses of treatment treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy
After completion of pemetrexed disodium and oxaliplatin patients undergo concurrent chemoradiotherapy
Blood samples are collected at baseline and periodically during study for biomarker and pharmacokinetic studies
Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last course
After completion of study treatment patients are followed periodically for up to 3 years
Primary
To evaluate the clinical response rate in patients with locally advanced squamous cell carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and oxaliplatin
Secondary
To evaluate the pathological complete response in patients who undergo surgical resection or post-induction biopsy
To assess toxicity of therapy including the assessment of quality of life fatigue and head and neck cancer-related symptoms
To predict response and toxicities based on pharmacogenomics genomics and proteomics
OUTLINE This is a nonrandomized open-label study Patients are assigned to 1 of 2 groups based on resectability of disease resectable vs nonresectable
Group I resectable disease Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1 Treatment repeats every 14 days for up to 4 courses If patient progresses before receiving 4 courses of treatment treatment will be discontinued and patient will proceed to surgery
After completion of pemetrexed disodium and oxaliplatin patients undergo surgical resection of disease
Group II nonresectable disease Patients receive treatment as in group I If patient progresses before receiving 4 courses of treatment treatment will be discontinued and patient will proceed to concurrent chemoradiotherapy
After completion of pemetrexed disodium and oxaliplatin patients undergo concurrent chemoradiotherapy
Blood samples are collected at baseline and periodically during study for biomarker and pharmacokinetic studies
Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last course
After completion of study treatment patients are followed periodically for up to 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-060100 | None | None | None |
| VU-VICC-HN-0582 | None | None | None |