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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00046423
First received: September 30, 2002
Last updated: July 14, 2008
Last verified: August 2006
  Purpose

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 Intervention Phase
Neoplasms
Metastases, Neoplasm
Drug: ABI-007
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Estimated Enrollment: 20
Study Start Date: April 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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 Perfomance 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046423

Locations
United States, North Carolina
Abraxis Bioscience, Inc.
Durham, North Carolina, United States, 27703
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Michael J Hawkins, M.D. Celgene Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046423     History of Changes
Other Study ID Numbers: CA-005-0
Study First Received: September 30, 2002
Last Updated: July 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Cancer
solid tumor
Advanced malignancy
Taxane therapy
Biopsy-proven diagnosis of advanced malignancy
Various solid tumors which are refractory

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014