A Phase 2 interventional study of Pemetrexed in Head and Neck Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 5 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Exclusion Criteria:
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Drug: Pemetrexed
500 mg/m2 IV every 3 weeks for 6 cycles
Also known as: ALIMTA
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.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
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).
Time frame: 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.
Time frame: Up to 2 years
Patients were enrolled to the study from March 2006 to January 2008
| Milestone | Pemetrexed |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| patients | Pemetrexed |
|---|---|
| Overall Response Rate | 0 |
Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
| percent of patients | Pemetrexed |
|---|---|
| fatigue | 80 |
| Hypercalcemia | 20 |
| Anemia | 20 |
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).
| Units on a scale | Pemetrexed |
|---|---|
| Baseline score | 524 ± 141.6 |
| End of Treatment score | 335.5 ± 185.9 |
Overall survival was measured from the time of initial study entry to death due to any cause.
| months | Pemetrexed |
|---|---|
| Overall Survival | 4.4 (1.4 to 15.4) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed | — | 0/5 (0%) | 5/5 (100%) |
| Event | Pemetrexed |
|---|---|
| FatigueGeneral disorders | 5/5 |
| NauseaGastrointestinal disorders | 4/5 |
| ConstipationGastrointestinal disorders | 3/5 |
| VomitingGastrointestinal disorders | 2/5 |
| Increased/Thicker salivaGastrointestinal disorders | 2/5 |
| Neck painMusculoskeletal and connective tissue disorders | 2/5 |
| PneumoniaInfections and infestations | 2/5 |
| DiarrheaGastrointestinal disorders | 1/5 |
| HeadacheNervous system disorders | 1/5 |
| HypercalcemiaMetabolism and nutrition disorders | 1/5 |
| Age, Continuous(years) | Pemetrexed |
|---|---|
| Median | 52 (49 to 71) |
| Sex: Female, Male(Participants) | Pemetrexed |
|---|---|
| Female | 2 |
| Male | 3 |
| Region of Enrollment(participants) | Pemetrexed |
|---|---|
| United States | 5 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pemetrexed
Ohio State University Comprehensive Cancer Center →