Docetaxel |
Taxotere |
Clinical Trial: Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage IV breast cancer recurrent breast cancer | Drug: docetaxel Drug: sulindac Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Sulindac and Docetaxel in Women With Metastatic or Recurrent Adenocarcinoma of the Breast
OBJECTIVES:
- Determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel.
- Determine the time to progression of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral sulindac twice daily. Patients also receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed within 3-4 weeks.
PROJECTED ACCRUAL: Approximately 12-33 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Metastatic or recurrent disease
- Measurable disease
- Bone only disease is not eligible
- No hematologic malignancy
- No carcinomatous meningitis and/or untreated or uncontrolled brain parenchymal disease
- At least 8 weeks since prior therapy for brain parenchymal disease and patient must be asymptomatic from CNS disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS: Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Premenopausal or postmenopausal
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- One of the following:
- SGOT and SGPT no greater than 2.5 times ULN AND
- Alkaline phosphatase no greater than ULN OR
- SGOT and SGPT no greater than ULN AND
- Alkaline phosphatase no greater than 4 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No unstable angina
- No uncontrolled atrial or ventricular arrhythmias
- No congestive heart failure
- No uncontrolled hypertension
Other:
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer
- No active unresolved infection
- No poorly controlled diabetes mellitus
- No prior hypersensitivity reactions to sulindac or Polysorbate 80
- No peripheral neuropathy grade 2 or greater
- No active peptic ulcer disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent biological response modifiers
- No concurrent trastuzumab (Herceptin)
Chemotherapy:
- No more than 1 prior chemotherapy regimen in the adjuvant setting
- No more than 1 prior chemotherapy regimen for recurrent or metastatic disease
- No prior docetaxel
- Prior paclitaxel allowed
- At least 1 week since prior chronic sulindac
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent sulindac
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 1 week since prior antibiotics
- At least 4 weeks since prior investigational agents
- No other concurrent investigational drugs
- No other concurrent antineoplastic therapy
- No concurrent chronic (full dose for more than 2 weeks) nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen sodium), including cyclo-oxygenase-2 inhibitors and salicylates (e.g., aspirin, mesalamine, azodisalicylate, salsalate, or sulfasalazine)
- No concurrent parenteral antibiotics
- Concurrent low-dose aspirin for cardiovascular prevention allowed
Location Information
Mary Cianfrocca, DO, Study Chair, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: June 6, 2002
ClinicalTrials.gov Identifier: NCT00039520
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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