Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
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Purpose
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 metastatic or recurrent salivary gland cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES |
| Estimated Enrollment: | 32 |
| Study Start Date: | March 1995 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Estimate the response rate in patients with metastatic or recurrent salivary gland cancer treated with paclitaxel (Taxol, TAX) by 3-hour infusion. II. Describe the toxicity of TAX in these patients.
OUTLINE: Single-Agent Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973.
PROJECTED ACCRUAL: Up to 32 patients/histology will be entered. If no response is observed in the first 14 patients in a particular histology, accrual to that group will close; if after 18 months annual accrual is less than 10 patients/histology, accrual to that group may close.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed salivary gland carcinoma that is metastatic or recurrent, including the following types: Mucoepidermoid carcinoma Adenocarcinoma Pathology review required Measurable disease required Lesion in a previously irradiated field must be progressing and biopsy- proven
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 3,000/mm3 ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hb at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No MI within the past 6 months No CHF No unstable arrhythmia No current antiarrhythmic, inotropic, or antianginal medication Other: No history of allergy to Cremophor No prior malignancy within 5 years except: Curatively treated nonmelanomatous skin cancer Curatively treated in-situ cancer of the cervix No concurrent malignancy Not pregnant or nursing Effective contraception strongly advised for fertile patients Blood/body fluid analyses to determine eligibility and imaging studies and scans/x-rays for tumor measurement completed within 14 days prior to registration
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifier therapy allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed with recovery Surgery: Prior surgery allowed with recovery
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00002632
Show 29 Study Locations
| Study Chair: | Harlan A. Pinto, MD | Stanford University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002632 History of Changes |
| Other Study ID Numbers: | CDR0000064057, E-1394 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 28, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eastern Cooperative Oncology Group:
|
stage IV salivary gland cancer recurrent salivary gland cancer high-grade salivary gland mucoepidermoid carcinoma salivary gland adenocarcinoma |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on February 27, 2015