Phase 2
Completed N=36
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Source: ClinicalTrials.gov NCT00248560 ↗Enrolled (actual)
36
Serious AEs
69.4%
Results posted
Aug 2014
Primary outcomePrimary: Response (Complete Response [CR] + Partial Response [PR]) — 6 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response (Complete Response [CR] + Partial Response [PR]) |
6 | — |
| SECONDARY Response Duration |
3.2 | — |
| SECONDARY Survival |
4.2 | — |
| SECONDARY Toxicity as Measured by Number and Grade of Adverse Events |
13; 10; 10; 3; 3; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00248560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.