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S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Registration Number
NCT00100789
Lead Sponsor
SWOG Cancer Research Network
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
gemcitabine paclitaxel combinationgemcitabine-
gemcitabine paclitaxel combinationpaclitaxel-
Primary Outcome Measures
NameTimeMethod
Overall Survival0 - 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.

Secondary Outcome Measures
NameTimeMethod
Progression-free Survival0 - 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.

Response9 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 DrugPatients 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.

Trial Locations

Locations (122)

Northeast Alabama Regional Medical Center

🇺🇸

Anniston, Alabama, United States

Mobile Infirmary Medical Center

🇺🇸

Mobile, Alabama, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

🇺🇸

Aurora, Colorado, United States

Veterans Affairs Medical Center - Denver

🇺🇸

Denver, Colorado, United States

Montrose Memorial Hospital Cancer Center

🇺🇸

Montrose, Colorado, United States

Exempla Lutheran Medical Center

🇺🇸

Wheat Ridge, Colorado, United States

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

🇺🇸

Valdosta, Georgia, United States

Kapiolani Medical Center at Pali Momi

🇺🇸

Aiea, Hawaii, United States

Cancer Research Center of Hawaii

🇺🇸

Honolula, Hawaii, United States

OnCare Hawaii, Incorporated - Lusitana

🇺🇸

Honolulu, Hawaii, United States

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Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States

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