A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies

Study Overview
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Brief Summary
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This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.

Detailed Description
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This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.

Official Title
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A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-hematologic Malignancies

Conditions
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Neoplasms, Metastases, Neoplasm

Intervention / Treatment
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* Drug: ABI-007


Participation Criteria
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Eligibility Criteria
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At least 18 years of age Life expectancy of at least 2 months Off all therapy for at least 3 weeks prior to study drug administration Biopsy-proven diagnosis of advanced malignancy Patients with solid tumors who have failed standard therapy Karnofsky Performance Status of 70% or 0-2 SWOG Performance Status Hemoglobin at least 9 White Blood Cell count of at least 3000/mm3 with absolute neutrophil count of at least 1500/mm3 Platelet count of at least 100,000/mm3 Serum Creatinine less than 2 mg/dL Transaminases less than 3X the upper limit of normal Patient must provide informed consent Serum Bilirubin less than 1.5 mg/dL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABI-007|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, solid tumor, Advanced malignancy, Taxane therapy, Biopsy-proven diagnosis of advanced malignancy, Various solid tumors which are refractory