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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00337376 |
Purpose
Rapamycin is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Abraxane is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of metastatic breast cancer, and is a promising drug that is being evaluated in clinical trials for treatment of other cancers. This is a phase I study designed to find out if different doses of Rapamycin, when combined with Abraxane, are safe and well tolerated.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Cancers |
Drug: Rapamune Drug: Abraxane |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of the mTOR Inhibitor Rapamycin (Rapamune, Sirolimus) in Combination With Abraxane (Paclitaxel Protein-Bound Particles) in Advanced Solid Cancers |
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Rapamune
Dose escalation as follows: 5mg PO, 10mg PO, 20mg PO, 40mg PO
Other Names:
Drug: Abraxane
intravenous administration of 100mg/m2 Abraxane over 30 minutes, weekly for three out of four consecutive weeks.
Other Name: Albumin-bound paclitaxel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)2.5 X institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance ≥50 mL/min/1.73 m² for patients with creatinine levels ≥1.5 ULN.
Exclusion Criteria:
Contacts and Locations| Contact: Jeannie Kluytenaar, RN | 203-785-6523 | Jeannie.kluytenaar@yale.edu |
| Contact: Michele Alguard | 203-737-5908 | michele.alguard@yale.edu |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Principal Investigator: | Maysa Abu-Khalaf, M.D. | Yale University |
More Information
| Responsible Party: | Maysa Abu-Khalaf, M.D. Principal Investigator, Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00337376 History of Changes |
| Other Study ID Numbers: | 0511000860 |
| Study First Received: | June 13, 2006 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Sirolimus Everolimus Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |