Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 8, 2004
Last updated: December 23, 2010
Last verified: January 2007

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 may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed tumor response as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event profile [ Designated as safety issue: Yes ]
  • Distribution of progression times [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2004
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer.


  • Determine the toxicity profile of this regimen in these patients.
  • Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed every 2 months until disease progression and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 20 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Granulocyte count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3


  • 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


  • Creatinine ≤ 1.5 times ULN


  • No myocardial infarction within the past 180 days
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmias


  • 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


Biologic therapy

  • Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated)


  • 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)


  • See Disease Characteristics
  • At least 30 days since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered


  • More than 7 days since prior parenteral antibiotic therapy
  • No other concurrent experimental drugs
  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 identifier: NCT00079118

  Show 162 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Study Chair: Edith A. Perez, MD Mayo Clinic
Investigator: Winston Tan, MD, FACP Mayo Clinic
  More Information

Additional Information:
Publications: Identifier: NCT00079118     History of Changes
Other Study ID Numbers: CDR0000354417, NCCTG-N0332
Study First Received: March 8, 2004
Last Updated: December 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on July 01, 2015