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Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer - Article


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Docetaxel

Taxotere



Clinical Trial: Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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:

PRIOR CONCURRENT THERAPY: Biologic therapy:

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


Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Mary Cianfrocca, DO,  Study Chair,  Fox Chase Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069390; FCCC-01031; FCCC-63723; NCI-G02-2080
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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November 18, 2008



Page Updated: October 3, 2005
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