Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug...

Detailed Description

OBJECTIVES: Primary * Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer. Secondary * Determine the toxic...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the breast
  • Metastatic disease
  • Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease
  • At least one unidimensionally measurable lesion
  • At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
  • Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed
  • Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung
  • The following are not considered measurable:
  • Bone lesions
  • Ascites
  • Leptomeningeal disease
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Cystic lesions
  • No known CNS metastases unless controlled by prior surgery and/or radiotherapy
  • Hormone receptor status:
  • Estrogen receptor (ER) and/or progesterone receptor (PR) status known
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Sex
  • Male or female
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Granulocyte count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin ≤ upper limit of normal (ULN)
  • Meets 1 of the following criteria:
  • AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
  • Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
  • AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No myocardial infarction within the past 180 days
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmias
  • Other
  • No active, unresolved infection
  • No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No grade 1 or greater sensory or motor neuropathy
  • No other concurrent severe condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated)
  • Chemotherapy
  • See Disease Characteristics
  • More than 14 days since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for metastatic disease
  • No prior irinotecan or docetaxel for metastatic disease
  • Docetaxel as adjuvant therapy allowed
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated)
  • Radiotherapy
  • See Disease Characteristics
  • At least 30 days since prior radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered
  • Other
  • More than 7 days since prior parenteral antibiotic therapy
  • No other concurrent experimental drugs

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2010

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT00079118

    Start Date

    April 1 2004

    End Date

    December 1 2010

    Last Update

    December 13 2016

    Active Locations (162)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 41 (162 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60507

    4

    St. Joseph Medical Center

    Bloomington, Illinois, United States, 61701