Head and Neck Cancer
Conditions
Keywords
head and neck cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGPemetrexed
500 mg/m2 IV every 3 weeks for 6 cycles
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced, metastatic, or recurrent head and neck cancers * Poor risk patients with ECOG performance status of 2
Exclusion criteria
* Prior treatment for recurrent or metastatic disease * No clinical or radiological evidence of brain metatases * Patients with bone only disease are not eligible * Patients with pleural or peritoneal effusion as only manifestation of diesase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | Up to 3 years | Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
| Impact of Pemetrexed Chemotherapy on Quality of Life | Baseline, End of Treatment [up to 3 years] | 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). |
| Overall Survival | Up to 2 years | Overall survival was measured from the time of initial study entry to death due to any cause. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled to the study from March 2006 to January 2008
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pemetrexed |
|---|---|
| Age, Continuous | 52 years |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemetrexed | Overall Response Rate | 0 patients |
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).
Time frame: Baseline, End of Treatment [up to 3 years]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemetrexed | Impact of Pemetrexed Chemotherapy on Quality of Life | Baseline score | 524 Units on a scale | Standard Deviation 141.6 |
| Pemetrexed | Impact of Pemetrexed Chemotherapy on Quality of Life | End of Treatment score | 335.5 Units on a scale | Standard Deviation 185.9 |
Secondary
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
Population: All patients were deceased at the time of terminating this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed | Overall Survival | 4.4 months |
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.
Time frame: Up to 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pemetrexed | Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | fatigue | 80 percent of patients |
| Pemetrexed | Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | Hypercalcemia | 20 percent of patients |
| Pemetrexed | Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer | Anemia | 20 percent of patients |