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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: sulindac

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Mary Cianfrocca, DO, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: June 6, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: stage IV breast cancer; recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Sulindac
• Other Study ID Numbers: CDR0000069390; P30CA006927 (U.S. NIH Grant/Contract); FCCC-01031; FCCC-63723; NCI-G02-2080