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: May 5, 2014
Last verified: May 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: June 2004 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 5, 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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014