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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100789
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : October 1, 2012
Last Update Posted : October 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: gemcitabine Drug: paclitaxel Phase 2

Detailed Description:


  • 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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: gemcitabine paclitaxel combination Drug: gemcitabine
3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
Other Names:
  • Gemzar
  • NSC-613327
Drug: paclitaxel
150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
Other Names:
  • Taxol
  • NSC-673089

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • No concurrent biologic or immunotherapy for SCCHN
  • No concurrent gene therapy for SCCHN


  • 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


  • At least 28 days since prior radiotherapy and recovered
  • No concurrent radiotherapy for SCCHN


  • Not specified


  • No other concurrent therapy for SCCHN

Information from the National Library of Medicine

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 identifier (NCT number): NCT00100789

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute

Responsible Party: Southwest Oncology Group Identifier: NCT00100789     History of Changes
Other Study ID Numbers: CDR0000407644
S0329 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2005    Key Record Dates
Results First Posted: October 1, 2012
Last Update Posted: October 1, 2012
Last Verified: August 2012

Keywords provided by Southwest Oncology Group:
stage IV
squamous cell carcinoma
oral cavity
nasal cavity
neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs