Head and Neck Cancer
Conditions
Keywords
recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
Brief summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
Detailed description
OBJECTIVES: Primary * Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel. Secondary * Determine the toxicity of this regimen in these patients. * Determine the duration of response and survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy beyond documentation of CR. After completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.
Interventions
DRUGdocetaxel
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
DRUGGemcitabine
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Metastatic, persistent, or recurrent disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy * No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Granulocyte count \> 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal Renal * Creatinine \< 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No peripheral neuropathy ≥ grade 2 * No active infection requiring systemic therapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site * No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80 * No other serious condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior taxane or gemcitabine * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics Other * No other concurrent therapy for this disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response (Complete Response [CR] + Partial Response [PR]) | every 8 weeks for approximately 8 - 48 weeks | 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 |
|---|---|---|
| Response Duration | Every 8 weeks | Response duration in months |
| Survival | Every 8 weeks | Overall Survival using the Kaplan-Meier method |
| Toxicity as Measured by Number and Grade of Adverse Events | Every 2 weeks | Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine, Docetaxel Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Gemcitabine, Docetaxel |
|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 36 |
| serious Total, serious adverse events | 25 / 36 |
Outcome results
Primary
Response (Complete Response [CR] + Partial Response [PR])
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: every 8 weeks for approximately 8 - 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine, Docetaxel | Response (Complete Response [CR] + Partial Response [PR]) | 6 participants |
95% CI: [0.08, 0.32]
Secondary
Response Duration
Response duration in months
Time frame: Every 8 weeks
Population: Only those patients that have a recorded CR or PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine, Docetaxel | Response Duration | 3.2 months |
Secondary
Survival
Overall Survival using the Kaplan-Meier method
Time frame: Every 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine, Docetaxel | Survival | 4.2 months |
Secondary
Toxicity as Measured by Number and Grade of Adverse Events
Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
Time frame: Every 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Tachycardia | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Syncope | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Anemia | 13 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Neutropenia | 10 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Hyponatremia | 10 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Dehydration | 3 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Fatigue | 3 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Dyspnea | 3 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Pneumonia | 3 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Thrombocytopenia | 2 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Febrile neutropenia | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Fluid retention | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Mucositis | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Hyperglycemia | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Constipation | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Anorexia | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Vomiting | 1 participants |
| Gemcitabine, Docetaxel | Toxicity as Measured by Number and Grade of Adverse Events | Other non-hematologic toxicity | 1 participants |