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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039520
• Other study ID #: CDR0000069390
• Secondary ID: P30CA006927FCCC-
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: May 5, 2014
• Start date: January 2002
• Est. completion date: July 2008

Study information

• Verified date: May 2014
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2008
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• sulindac

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,