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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Amgen |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00267046 |
Purpose
Primary:
Exploratory:
| Condition | Intervention | Phase |
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Sarcoma Oral Mucositis |
Drug: Palifermin Drug: Placebo Drug: Doxorubicin Drug: Ifosfamide Drug: Vincristine Drug: Cisplatin |
Phase II |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Ifosfamide Cisplatin Vincristine sulfate Vincristine Palifermin |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study to Evaluate the Pharmacokinetics, Safety, and Obtain a Preliminary Efficacy Assessment of Palifermin in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide |
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2005 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Palifermin + Chemotherapy (AI Regimen)
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Drug: Palifermin
180 mcg/kg 3 days pre chemotherapy
Drug: Doxorubicin
30 mg/m^2 IV continuous infusion for 72 hours (h); days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Drug: Ifosfamide
2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen.
Drug: Vincristine
2 mg IV by rapid administration on day 0 (for patients with small cell histology receiving the AI Regimen).
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2: Placebo Comparator
Placebo + Chemotherapy (AI Regimen)
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Drug: Placebo
a single dose of placebo 3 days pre chemotherapy
Drug: Doxorubicin
30 mg/m^2 IV continuous infusion for 72 hours (h); days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Drug: Ifosfamide
2.5 g/m^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m^2); for patients receiving the AI Regimen.
Drug: Vincristine
2 mg IV by rapid administration on day 0 (for patients with small cell histology receiving the AI Regimen).
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3: Experimental
Palifermin + Chemotherapy (AP Regimen)
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Drug: Palifermin
180 mcg/kg 3 days pre chemotherapy
Drug: Doxorubicin
30 mg/m^2 IV continuous infusion for 72 hours (h); days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Drug: Cisplatin
120 mg/m^2 on day 0, for patients receiving the AP Regimen.
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4: Placebo Comparator
Placebo + Chemotherapy (AP Regimen)
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Drug: Placebo
a single dose of placebo 3 days pre chemotherapy
Drug: Doxorubicin
30 mg/m^2 IV continuous infusion for 72 hours (h); days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Drug: Cisplatin
120 mg/m^2 on day 0, for patients receiving the AP Regimen.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |||||
| U.T.M.D. Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Amgen |
| Principal Investigator: | Saroj Vadhan-Raj, M.D. | University of Texas MDAnderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor ) |
| Study ID Numbers: | 2004-0511 |
| First Received: | December 19, 2005 |
| Last Updated: | April 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00267046 |
| Health Authority: | United States: Food and Drug Administration |
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