Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NCCTG-N0332 N0332, NCT00079118

Objectives

Primary

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

Secondary

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

Entry Criteria

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

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

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/mm³
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Confirmed tumor response as measured by RECIST criteria

Adverse event profile
Distribution of progression times
Overall survival

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.

Tan WW, Hillman D, Salim M, et al.: N0332 phase II trial of weekly irinotecan and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group trial. [Abstract] Breast Cancer Res Treat 106 (1): A-1087, S71-2, 2007.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Edith Perez, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Winston Tan, MD, FACP, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
Trial Start Date		2004-04-09
Registered in ClinicalTrials.gov		NCT00079118
Date Submitted to PDQ		2004-01-22
Information Last Verified		2007-01-12
NCI Grant/Contract Number		CA25224

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