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

NCT ID: NCT00039520

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2008-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

sulindac

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Cianfrocca, DO

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FCCC-01031

Identifier Type: -

Identifier Source: secondary_id

FCCC-63723

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2080

Identifier Type: -

Identifier Source: secondary_id

CDR0000069390

Identifier Type: -

Identifier Source: org_study_id