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A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mary Cianfrocca, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069390

NCT ID:

NCT00039520

Start Date:

January 2002

Completion Date:

July 2008

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111