Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
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Purpose
The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.
| Condition | Intervention |
|---|---|
|
Sarcoma Nausea Vomiting |
Drug: Palonosetron - Single Dose Drug: Palonosetron - Triple Dose Drug: Adriamycin Drug: Ifosfamide chemotherapy (AI) Drug: Zinecard Drug: Mesna Drug: Vincristine Drug: Dexamethasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI) |
- Palonosetron Response Rate in the 10 Day Study Cycle [ Time Frame: 10 days ] [ Designated as safety issue: No ]Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.
| Enrollment: | 51 |
| Study Start Date: | December 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Palonosetron - 1 Dose
Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0). Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology). |
Drug: Palonosetron - Single Dose
0.25 mg by vein for 1 dose (day 0).
Other Name: Aloxi
Drug: Adriamycin
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Other Names:
Drug: Ifosfamide chemotherapy (AI)
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
Other Name: Ifex
Drug: Zinecard
750 mg/m2 as an IV bolus.
Other Name: Dexrazoxane
Drug: Mesna
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
Other Name: mesnex
Drug: Vincristine
2 mg IV by rapid administration on day 0 (for patients with small cell histology). For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only. IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
Other Names:
|
|
Active Comparator: Palonosetron - 3 Doses
Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4). Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology). |
Drug: Palonosetron - Triple Dose
0.25 mg by vein for 3 doses (days 0, 2, 4).
Other Name: Aloxi
Drug: Adriamycin
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Other Names:
Drug: Ifosfamide chemotherapy (AI)
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
Other Name: Ifex
Drug: Zinecard
750 mg/m2 as an IV bolus.
Other Name: Dexrazoxane
Drug: Mesna
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
Other Name: mesnex
Drug: Vincristine
2 mg IV by rapid administration on day 0 (for patients with small cell histology). For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only. IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.
- Must be between the ages of 18 and 65 years of age.
- Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
- Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and Serum glutamic pyruvic transaminase (SGPT) <3 * normal) functions.
- Karnofsky Performance Status >/= 80.
- Signed informed consent form.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication.
- Patients with symptomatic or untreated metastatic disease to CNS.
- Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia.
- Patients with known hypersensitivity to 5-HT3 antagonists.
- Any vomiting or >/= grade 2 nausea in the 24 hours preceding chemotherapy.
- Ongoing vomiting from any organic etiology.
- Radiotherapy within 2 weeks of study entry.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Saroj Vadhan-Raj, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00410488 History of Changes |
| Other Study ID Numbers: | 2005-0664 |
| Study First Received: | December 11, 2006 |
| Results First Received: | June 28, 2012 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Sarcoma Palonosetron Aloxi Nausea Vomiting |
Additional relevant MeSH terms:
|
Nausea Vomiting Sarcoma Signs and Symptoms, Digestive Signs and Symptoms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Mesna Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Isophosphamide mustard Doxorubicin Ifosfamide |
Razoxane Vincristine BB 1101 Palonosetron Protective Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on June 18, 2013