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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00039520
First received: June 6, 2002
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: sulindac
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 10
Study Start Date: January 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039520

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Mary Cianfrocca, DO Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00039520     History of Changes
Other Study ID Numbers: CDR0000069390, P30CA006927, FCCC-01031, FCCC-63723, NCI-G02-2080
Study First Received: June 6, 2002
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Fox Chase Cancer Center:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Sulindac
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014