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

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00046423

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Metastases, Neoplasm	Drug: ABI-007	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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