Status:
COMPLETED
Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Solid Tumor
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the Maximally Tolerable Dose (MTD) of KOS-1022 when administered weekly in combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients with advanced solid t...
Eligibility Criteria
Inclusion
- KPS performance status \>= 70%
- Schedule A: all patients must have a histologically confirmed solid tumor malignancy. Schedule B: patients must have metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC"). Patients are not required to have measurable disease for this investigation. Disease must be assessed within 28 days prior to treatment initiation
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2 (except for alopecia)
- The following laboratory results, within 10 days of KOS-1022 administration:
- Hemoglobin \>= 8.5 g/dL
- Absolute neutrophils count \>= 1.5 x 10\*9\* /L
- Platelet count \>= 75 x 10\*9\*/L
- Serum bilirubin \<= 2 x ULN
- AST and ALT \<= 2.5 x ULN
- Serum creatinine \<= 2 x ULN
Exclusion
- Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing trastuzumab
- Pregnant or breast-feeding women. Male patients must be surgically sterile or agree to use an acceptable method of contraception
- Known active CNS metastases
- Administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
- Patients with Grade 2 or higher dyspnea at rest on room air; patients with other clinically significant pulmonary co-morbidity(s) that might predispose the patient to pulmonary toxicity
- Moderately severe dry eye
- Prior pulmonary toxic chemotherapy (e.g, bleomycin or carmustine)
- Congestive heart failure, or a left ventricular ejection fraction (LVEF)
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
- Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00803556
Start Date
January 1 2006
End Date
August 1 2009
Last Update
June 27 2011
Active Locations (2)
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1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021