Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

NCT00410488 | Completed Results

• 1 other identifier: 2005-0664
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma; Nausea; Vomiting

Keywords

Sarcoma; Palonosetron; Aloxi; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Palonosetron Response Rate in the 10 Day Study Cycle

  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.

  10 days

Study Arms (2)

Palonosetron - 1 Dose

ACTIVE COMPARATOR

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; Drug: Adriamycin; Drug: Ifosfamide chemotherapy (AI); Drug: Zinecard; Drug: Mesna; Drug: Vincristine; Drug: Dexamethasone

Palonosetron - 3 Doses

ACTIVE COMPARATOR

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; Drug: Adriamycin; Drug: Ifosfamide chemotherapy (AI); Drug: Zinecard; Drug: Mesna; Drug: Vincristine; Drug: Dexamethasone

Interventions

Palonosetron - Single Dose DRUG

0.25 mg by vein for 1 dose (day 0).

Also known as: Aloxi

Palonosetron - 1 Dose

Palonosetron - Triple Dose DRUG

0.25 mg by vein for 3 doses (days 0, 2, 4).

Also known as: Aloxi

Palonosetron - 3 Doses

Adriamycin DRUG

75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.

Also known as: Doxorubicin, Doxorubicin Hydrochloride, Adriamycin PFS, Adrimaycin RDF, Rubex

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Ifosfamide chemotherapy (AI) DRUG

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.

Also known as: Ifex

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Zinecard DRUG

750 mg/m2 as an IV bolus.

Also known as: Dexrazoxane

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Mesna DRUG

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).

Also known as: mesnex

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Vincristine DRUG

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.

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Dexamethasone DRUG

IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.

Also known as: Decadron, Dexamethasone acetate

Palonosetron - 1 Dose; Palonosetron - 3 Doses

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma; Nausea; Vomiting

Interventions

Palonosetron; Doxorubicin; Ifosfamide; Dexrazoxane; Mesna; Vincristine; Dexamethasone; Calcium Dobesilate; dexamethasone acetate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Razoxane; Diketopiperazines; Piperazines; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids

Results Point of Contact

• Title: Saroj Vadhan-Raj, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Saroj Vadhan-Raj, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 22, 2013
• Results First Posted: March 22, 2013

Record last verified: 2013-02

Locations

US (1)