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Completed

NCT Number: NCT00100789

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Laryngeal Diseases Lymphoid Interstitial Pneumonia Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

Other names: Gemzar, NSC-613327

paclitaxel

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 7, 2005
Registry last updated
Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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