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This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.
Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.
Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.
Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental | pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 mg/m2 IV every 3 weeks for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Up to 3 years |
| Impact of Pemetrexed Chemotherapy on Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anterpreet Neki, M.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22434360 | Derived | Urba S, van Herpen CM, Sahoo TP, Shin DM, Licitra L, Mezei K, Reuter C, Hitt R, Russo F, Chang SC, Hossain AM, Frimodt-Moller B, Koustenis A, Hong RL. Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study. Cancer. 2012 Oct 1;118(19):4694-705. doi: 10.1002/cncr.27449. Epub 2012 Mar 20. |
| Label | URL |
|---|---|
| Jamesline | View source |
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Patients were enrolled to the study from March 2006 to January 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed | pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed | pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | patients | Up to 3 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pemetrexed | pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anterpreet Neki | Ohio State University Comprehensive Cancer Center | 614-257-2900 | Anterpreet.Neki@osumc.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health). |
| Baseline, End of Treatment [up to 3 years] |
| Overall Survival | Overall survival was measured from the time of initial study entry to death due to any cause. | Up to 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Posted | Number | percent of patients | Up to 3 years |
|
|
|
| Secondary | Impact of Pemetrexed Chemotherapy on Quality of Life | Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health). | Posted | Mean | Standard Deviation | Units on a scale | Baseline, End of Treatment [up to 3 years] |
|
|
|
| Secondary | Overall Survival | Overall survival was measured from the time of initial study entry to death due to any cause. | All patients were deceased at the time of terminating this study. | Posted | Median | Full Range | months | Up to 2 years |
|
|
|
| 0 |
| 5 |
| 5 |
| 5 |
| Vomiting | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE version 3 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE version 3 | Systematic Assessment |
|
| Increased/Thicker saliva | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Body jerking | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Systematic Assessment |
|
| Gum pain | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE version 3 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 3 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Loss of balance | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Systematic Assessment |
|
| Increased secretions | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Increased urination | Renal and urinary disorders | CTCAE version 3 | Systematic Assessment |
|
| Vocal changes | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | CTCAE version 3 | Systematic Assessment |
|
| Disorientation | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
|
| Rapid Heart rate | Cardiac disorders | CTCAE version 3 | Systematic Assessment |
|
| Bleeding from Tumor | Vascular disorders | CTCAE version 3 | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE version 3 | Systematic Assessment |
|
| ALT | Investigations | CTCAE version 3 | Systematic Assessment |
|
| AST | Investigations | CTCAE version 3 | Systematic Assessment |
|
| Gamma-Glutamyl transpeptidase | Investigations | CTCAE version 3 | Systematic Assessment |
|
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| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |