Status:
COMPLETED
Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by bl...
Detailed Description
OBJECTIVES: Primary * Determine the safety profile, maximum tolerated dose, and recommended phase II dose of docetaxel when administered with imatinib mesylate in patients with locally advanced or m...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Stage IIIB, IIIC, or IV disease
- Measurable or evaluable disease
- Stable brain metastases allowed provided prior surgery or radiotherapy was completed more than 90 days ago
- No documented or suspected leptomeningeal disease
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Male or female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- 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 for AST or ALT AND alkaline phosphatase:
- AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
- AST or ALT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
- No known acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
- Renal
- Creatinine ≤ 1.5 mg/dL
- Cardiovascular
- No New York Heart Association class III or IV heart disease
- No congestive heart failure
- No myocardial infarction within the past 6 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No other primary malignancy except those malignancies that are clinically insignificant AND do not require active intervention
- No other concurrent severe and/or life-threatening medical disease
- No significant history of noncompliance to medical regimens or inability to grant reliable informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 14 days since prior systemic trastuzumab (Herceptin®)
- No concurrent trastuzumab
- No concurrent biologic therapy for the primary malignancy
- Chemotherapy
- Prior taxane therapy, including docetaxel, in the adjuvant or metastatic setting allowed
- At least 21 days since prior systemic chemotherapy (14 days for weekly or oral chemotherapy and 42 days for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- Endocrine therapy
- At least 14 days since prior systemic hormonal therapy
- No concurrent antiestrogen therapy
- No concurrent routine systemic corticosteroid therapy except as premedication for chemotherapy
- Concurrent megestrol allowed only as an appetite stimulant
- Radiotherapy
- See Disease Characteristics
- At least 14 days since prior radiotherapy
- No prior radiotherapy to only site of measurable/evaluable disease unless there is new evidence of post-radiotherapy disease progression
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- More than 2 weeks since prior major surgery
- Other
- Recovered from all prior therapy
- At least 14 days since prior daily or weekly systemic investigational treatment
- No concurrent warfarin for full anticoagulation
- Concurrent low-dose warfarin (e.g., 1 mg/day) allowed for prophylaxis of central venous access
- No concurrent treatment with any of the following:
- Phenobarbital
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Hypericum perforatum (St. John's wort)
- No other concurrent therapies for the primary malignancy
- No other concurrent investigational drugs or systemic therapy
- No concurrent bisphosphonates unless started before study therapy
- No concurrent grapefruit juice
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00080665
Start Date
December 1 2003
End Date
January 1 2011
Last Update
April 24 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410