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

Temple University Health System (TUHS)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: sulindac

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00039520

P30CA006927 (U.S. NIH Grant/Contract)

FCCC-63723

CDR0000069390

NCI-G02-2080

FCCC-01031

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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