Clinical trial NCT00039520: Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Official title: A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Mary Cianfrocca, DO
role: STUDY_CHAIR
References: