Head and Neck Cancer
Conditions
Keywords
advanced, head, neck, cancer
Brief summary
The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.
Detailed description
This research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (SCCHN). Pemetrexed and gemcitabine have helped fight against SCCHN when each was given by itself. This study is different from others because it tests these two drugs together, which has not been tried before in patients with SCCHN. We will see how well these drugs can work to help to control or shrink your cancer. We also want to find out what effects (good and bad) gemcitabine and pemetrexed have on you and your head and neck cancer. We do not know if these drugs will help you. Your cancer might get better or it might get worse. It might not have any effect on your condition. We can use what we learn from this research study to help other people with the same cancer.
Interventions
DRUGpemetrexed
pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
DRUGgemcitabine
gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
Sponsors
Eli Lilly and Company
Fox Chase 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
* Diagnosis of squamous cell cancer of the head and neck - unresectable or metastatic. Must have measurable disease by RECIST. * Karnofsky performance status greater than or equal to 60% * Up to one prior systemic chemotherapy, immunotherapy allowed in the advanced or metastatic setting. This does not include prior chemotherapy, immunotherapy used with radiotherapy (ie concurrent with radiation therapy or as and induction regimen pror to definitive radiation therapy). * At least 4 weeks from prior radiation or chemotherapy, must have recovered from all acute effects of treatment. * Adequate organ and marrow function * Negative pregnancy test. Agree to use birth control during and for 3 months after last dose of study drug. * At least 18 years of age. * Sign an informed consent and HIPAA consent. * Must be able to take and absorb enteral medication.
Exclusion criteria
* Serious concomitant systemic disorder that would compromise safety or ability to complete study. * Prior treatment with gemcitabine or pemetrexed within the previous year, unless used concurrently with radiation therapy. * Pregnancy or breastfeeding. * Symptomatic or uncontrolled brain mets. If treated, must be off steroids for at least 2 weeks. * Inability or unwilling to take folic acid, vitamin B12, or dexamethasone. * Treatment within last 30 days with a drug that has not received regulatory approval for any indication. * Inability to interrupt and NSAID or salicylate with a long half-life (piroxicam or nabumetone) for a 5 day period. * Presence of clinically relevant third space fluid that cannot be controlled by drainage or other procedure prior to study entry. * Active, concurrent, invasive malignancy requiring ongoing treatment. * Corticosteroids impermissible unless for adrenal failure, septic shock or as temporizing measure for symptomatic pain, breathing, or rash.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 1 year | 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 |
|---|---|---|
| Time to Progression | 1 year | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Overall Survival | 1 year | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pemetrexed and Gemcitabine pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Pemetrexed and Gemcitabine |
|---|---|
| Age, Continuous | 64 years |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 17 |
| other Total, other adverse events | 17 / 17 |
| serious Total, serious adverse events | 4 / 17 |
Outcome results
Primary
Objective 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: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pemetrexed and Gemcitabine | Objective Response Rate | 2 Participants |
Secondary
Overall Survival
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed and Gemcitabine | Overall Survival | 5.9 months |
Secondary
Time to Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemetrexed and Gemcitabine | Time to Progression | 5.9 months |