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

NCT00100789 | Completed Phase 2 Results

• 3 other identifiers: CDR0000407644S0329U10CA032102
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 123

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.

Conditions

Head and Neck Cancer

Keywords

Recurrent; stage IV; squamous cell carcinoma; hypopharynx; larynx; lip; oral cavity; nasopharynx; oropharynx; paranasal; nasal cavity; metastatic; neck cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  0 - 3 years

Secondary Outcomes (3)

• Progression-free Survival

  0 - 3 years

• Response

  9 weeks - 3 years

• Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

  Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.

Study Arms (1)

gemcitabine paclitaxel combination

EXPERIMENTAL

Drug: gemcitabine; Drug: paclitaxel

Interventions

gemcitabine DRUG

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

Also known as: Gemzar, NSC-613327

gemcitabine paclitaxel combination

paclitaxel DRUG

150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Also known as: Taxol, NSC-673089

gemcitabine paclitaxel combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (123)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36202, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

Cancer Research Center of Hawaii

Honolula, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Christus Schumpert Cancer Treatment Center

Shreveport, Louisiana, 71101, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metro Health Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49442, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, 12801, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Center for Cancer Medicine and Blood Disorders, PA

El Paso, Texas, 79902, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

UMC Southwest Cancer and Research Center

Lubbock, Texas, 79415-3364, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115, United States

Location

Sentara Cancer Institute at Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Group Health Central Hospital

Seattle, Washington, 98104-1387, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence; Carcinoma, Squamous Cell; Laryngeal Diseases; Lymphoid Interstitial Pneumonia; Neoplasm Metastasis

Interventions

Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Omer Kucuk, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2005
• First Posted: January 7, 2005
• Study Start: January 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 1, 2012
• Results First Posted: October 1, 2012

Record last verified: 2012-08

Locations

US (123)