Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00503997
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
A patient may not be enrolled in the trial if any of the following criteria are met:
- Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
- Patients with known hypersensitivity to any of the components of Oxaliplatin and Pemetrexed
- Patients who received any chemotherapy, radiation therapy or surgical resection other than diagnostic biopsies for HNSCC prior to the first scheduled day of protocol treatment
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment(investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Peripheral neuropathy ≥ Grade 2
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent,cooperate and participate in the study, or interferes with the interpretation of the results.
- History of allogeneic transplant
- Known HIV (active, previously treated or both)
- Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description drug therapy pemetrexed disodium - drug therapy oxaliplatin -
- Primary Outcome Measures
Name Time Method Patient Response to Treatment Measured by RECIST Criteria at 8 weeks RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Purchase Cancer Group - Paducah
🇺🇸Paducah, Kentucky, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸Nashville, Tennessee, United States
MBCCOP - Meharry Medical College - Nashville
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Mitchell Memorial Cancer Center at Owensboro Medical Health System
🇺🇸Owensboro, Kentucky, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States