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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Eisai Inc. |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00410488 |
Purpose
Objectives:
| Condition | Intervention |
|---|---|
|
Sarcoma Nausea Vomiting |
Drug: Palonosetron |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI) |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Palonosetron X 1 Dose: Active Comparator |
Drug: Palonosetron
Arm 1: 0.25 mg by vein x 1 dose (day 0). Arm 2: 0.25 mg by vein x 3 doses (days 0, 2, 4). |
| Palonosetron X 3 Doses: Experimental |
Drug: Palonosetron
Arm 1: 0.25 mg by vein x 1 dose (day 0). Arm 2: 0.25 mg by vein x 3 doses (days 0, 2, 4). |
Hide Detailed DescriptionPalonosetron is a drug that is designed to prevent and treat nausea and vomiting that is caused by chemotherapy.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate) and weight. You will have blood collected (about 3 teaspoons) for routine tests. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will have several blood samples taken (about 3 teaspoons each). Researchers will use the samples to monitor blood counts during chemotherapy and periods of myelosuppression (a condition in which bone marrow activity is decreased). These blood samples will be taken at least 2 times a week, and at certain times, they will be taken once a day. You will be asked to fill out a QOL questionnaire about nausea and vomiting, at least 2 times during Cycle 1 (one cycle lasts 21 days). It will take about 10 minutes to complete the questionnaire.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive one dose of palonosetron on Day 0. Participants in the other group will receive 3 doses of palonosetron on Days 0, 2, and 4. Palonosetron will be given to participants in both groups, as an intravenous (IV--through a needle in your vein) infusion over 30 minutes.
You will be asked to keep a study diary during the treatment period. Study personnel will give you the diary and tell you how to complete it. Your side effects (including how severe they are) and medication doses need to be recorded in your diary every day. You will be asked to return your diary at each post-treatment return visit (about every 3 weeks).
While you are on this study, you will receive chemotherapy as part of your standard treatment. All participants will receive at least 2 cycles of adriamycin and ifosfamide chemotherapy (AI). A cycle is 3 weeks long. You may receive up to 6 cycles of adriamycin and ifosfamide. Adriamycin will be given as one large injection through a central venous catheter (plastic tube and needle placed under the collarbone) on Day 0. Ifosfamide will be given over 3 hours every day for 4 days (Days 0-3). Zinecard will be given as one large injection through the catheter on Day 0. Mesna will be given as a 24-hour infusion every day for 4 days through the same catheter (Days 0-3). Zinecard and mesna are given as standard of care. Zinecard is used to protect against heart-related side effects. Mesna is used to protect against bladder-related side effects. For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.
You may be treated as an outpatient or an inpatient. You will be asked to return to M. D.Anderson every 3 weeks for evaluation of your disease, by having a chest x-ray, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, and a physical exam performed. Additional blood samples (about 3 teaspoons) will be taken before each cycle and as often as needed to measure your blood counts and electrolytes (minerals in the body) to monitor any imbalances.
You will be asked to contact the study doctor or nurse about any bad side effects you experience or any medications (over-the-counter or prescription) you take during the treatment period. You will also be asked to notify your other doctors (separate from the study doctors) that you are participating in this research study.
Your treatment will continue for at least 6 cycles, unless your disease gets worse or you experience intolerable side effects. If you experience any intolerable side effects or your disease gets worse while on this study, you may be taken off this study.
Once you stop treatment, you will have what is called an end-of-study visit. During this visit, you will be evaluated for your disease status with CT and MRI scans. You will have your vital signs and weight measured. You will be asked about any medications you have taken since your last visit and any bad side effects that you have experienced. You will also have a final blood draw (about 3 teaspoons) for routine tests.
Your participation in this study should end at about 18 weeks (4 to 5 months).
Once you go off this study, you will have standard follow-up as is required by your doctor.
This is an investigational study. Palonosetron is FDA approved and is commercially available.
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pamela Walker, RN | 713-745-2767 |
| United States, Texas | |
| The University of Texas M.D.Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Saroj Vadhan-Raj, MD | |
| Principal Investigator: | Saroj Vadhan-Raj, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor ) |
| Study ID Numbers: | 2005-0664 |
| Study First Received: | December 11, 2006 |
| Last Updated: | June 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00410488 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Sarcoma Palonosetron Aloxi Nausea Vomiting |
|
Neurotransmitter Agents Vomiting Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Signs and Symptoms |
Neoplasms, Connective and Soft Tissue Serotonin Antagonists Neoplasms Ifosfamide Palonosetron Serotonin Agents Therapeutic Uses Sarcoma Nausea Antineoplastic Agents, Alkylating Alkylating Agents |
