Head and Neck Cancer Clinical Trial
Official title:
Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck
NCT number | NCT00002922 |
Other study ID # | CDR0000065327 |
Secondary ID | E-3395 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 21, 1997 |
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2001 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck (including nasopharynx) that is considered incurable with surgery or radiation therapy Bidimensionally measurable disease Patients whose only site of measurable disease is within a previous radiation port must have documented progressive disease or biopsy-proven recurrence after the completion of radiotherapy No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No history of ventricular arrhythmias or symptomatic bradyarrhythmia Other: No significant detectable infection Not pregnant or nursing No other active malignancies Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interleukin-2, interferons, and monoclonal antibodies allowed Recovered from prior therapy Chemotherapy: Prior paclitaxel infusion no greater than 24 hours for recurrent or metastatic disease required Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered from any prior major surgery |
Country | Name | City | State |
---|---|---|---|
South Africa | Pretoria Academic Hospital | Pretoria | |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | New England Medical Center Hospital | Boston | Massachusetts |
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago | Illinois |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania |
United States | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia |
United States | Veterans Affairs Medical Center - East Orange | East Orange | New Jersey |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Stanford University Medical Center | Stanford | California |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States, South Africa,
Langer CJ, Li Y, Jennings T, DeConti RC, Nair S, Cohen RB, Forastiere AA; Eastern Cooperative Oncology Group. Phase II evaluation of 96-hour paclitaxel infusion in advanced (recurrent or metastatic) squamous cell carcinoma of the head and neck (E3395): a — View Citation
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