TriangleNCT00100789 · REGISTRY CONDITION SEARCH
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2012-10-01
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) * Recurrent, persistent, or newly diagnosed metastatic disease * Measurable or non-measurable disease * No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No serious organ dysfunction * No serious comorbid conditions that would preclude study treatment * No history of hypersensitivity reaction to products containing polysorbate 80 * No active infection requiring systemic antibiotic therapy * No symptomatic sensory neuropathy ≥ grade 2 * 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 * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic or immunotherapy for SCCHN * No concurrent gene therapy for SCCHN Chemotherapy * No prior chemotherapy for recurrent or newly diagnosed metastatic disease * At least 6 months since prior induction or adjuvant chemotherapy * No more than 1 prior induction or adjuvant regimen * No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy * No other concurrent chemotherapy for SCCHN Endocrine therapy * Not specified Radiotherapy * At least 28 days since prior radiotherapy and recovered * No concurrent radiotherapy for SCCHN Surgery * Not specified Other * No other concurrent therapy for SCCHN
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: gemcitabine
- Drug: paclitaxel
- label
- gemcitabine paclitaxel combination
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- gemcitabine paclitaxel combination
- description
- 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
- name
- gemcitabine
- other Names
- Gemzar
- NSC-613327
- type
- DRUG
- arm Group Labels
- gemcitabine paclitaxel combination
- description
- 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
- name
- paclitaxel
- other Names
- Taxol
- NSC-673089
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 67
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- measure
- Overall Survival
- time Frame
- 0 - 3 years
- secondary Outcomes
- description
- Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
- measure
- Progression-free Survival
- time Frame
- 0 - 3 years
- description
- Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
- measure
- Response
- time Frame
- 9 weeks - 3 years
- description
- Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- measure
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
- time Frame
- Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
Full study description
- brief Summary
- RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
- detailed Description
- OBJECTIVES: * Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel. * Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.
Source references
Source notices and limitations
Discovery and provenance
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- query cond
- Hypopharyngeal Cancer
- query disease state id
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Preserved source evidence · Not medical advice