S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00100789|
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: gemcitabine Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: gemcitabine paclitaxel combination||
3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
Other Names:Drug: paclitaxel
150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
- Overall Survival [ Time Frame: 0 - 3 years ]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.
- Progression-free Survival [ Time Frame: 0 - 3 years ]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.
- Response [ Time Frame: 9 weeks - 3 years ]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.
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100789
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|Principal Investigator:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|