A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies
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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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2000 |
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 |
- 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| United States, North Carolina | |
| Abraxis Bioscience, Inc. | |
| Durham, North Carolina, United States, 27703 | |
| 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:
|
Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Paclitaxel Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013