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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00100789
First received: January 6, 2005
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: gemcitabine
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 0 - 3 years ] [ Designated as safety issue: No ]
    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:
  • Progression-free Survival [ Time Frame: 0 - 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 67
Study Start Date: January 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100789

  Show 123 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00100789     History of Changes
Other Study ID Numbers: CDR0000407644, S0329, U10CA032102
Study First Received: January 6, 2005
Results First Received: July 12, 2012
Last Updated: August 29, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
Recurrent
stage IV
squamous cell carcinoma
hypopharynx
larynx
lip
oral cavity
nasopharynx
oropharynx
paranasal
nasal cavity
metastatic
neck cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014