Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
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ClinicalTrials.gov Identifier: NCT00002632 |
Recruitment Status
:
Completed
First Posted
: June 10, 2004
Last Update Posted
: August 29, 2013
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: paclitaxel | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Primary Purpose: | Treatment |
Official Title: | PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES |
Study Start Date : | March 1995 |
Actual Primary Completion Date : | May 2002 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002632

Study Chair: | Harlan A. Pinto, MD | Stanford University |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00002632 History of Changes |
Other Study ID Numbers: |
CDR0000064057 E-1394 |
First Posted: | June 10, 2004 Key Record Dates |
Last Update Posted: | August 29, 2013 |
Last Verified: | August 2013 |
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:
Salivary Gland Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases |
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |