Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

NCT01490060 | Completed Results

• 2 other identifiers: 2011-0620NCI-2012-00011
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied. Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Conditions

Sarcoma; Chemotherapy-induced Nausea and Vomiting; Effects of Chemotherapy; Adverse Effects of Medical Drugs

Keywords

cancer; fosaprepitant; Ifosfamide-based Multi-day Chemotherapy; Chemotherapy-induced nausea and vomiting; CINV; multi-day chemotherapy regimens; antiemetics; adverse effect; doxorubicin plus ifosfamide; AI; AI and vincristine; VAI; aprepitant; prevention; nausea; vomiting; emetogenic chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete Response

  Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.

  From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).

Study Arms (2)

Single Dose Day 1

EXPERIMENTAL

Arm 1, Single Dose: Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 or Day 1 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Drug: Fosaprepitant; Drug: Dexamethasone; Drug: 5HT3 receptor antagonist; Drug: Ifosfamide-based chemotherapy (AI); Drug: Doxorubicin; Drug: Mesna; Drug: Ifosfamide; Drug: Vincristine

Two Doses Day 1 + Day 4

EXPERIMENTAL

Arm 2, Two Doses: Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 or Day 1 + Day 4 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Drug: Fosaprepitant; Drug: Dexamethasone; Drug: 5HT3 receptor antagonist; Drug: Ifosfamide-based chemotherapy (AI); Drug: Doxorubicin; Drug: Mesna; Drug: Ifosfamide; Drug: Vincristine

Interventions

Fosaprepitant DRUG

150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.

Also known as: Fosaprepitant Dimeglumine

Single Dose Day 1; Two Doses Day 1 + Day 4

Dexamethasone DRUG

Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)

Also known as: Dexamethasone acetate, Decadron

Single Dose Day 1; Two Doses Day 1 + Day 4

5HT3 receptor antagonist DRUG

5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy

Single Dose Day 1; Two Doses Day 1 + Day 4

Ifosfamide-based chemotherapy (AI) DRUG

Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.

Single Dose Day 1; Two Doses Day 1 + Day 4

Doxorubicin DRUG

25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

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

Single Dose Day 1; Two Doses Day 1 + Day 4

Mesna DRUG

Prior to ifosfamide (Day 1) - 500 mg/m\^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m\^2. The mesna infusion complete 24 hours after last dose of ifosfamide.

Also known as: Mesnex

Single Dose Day 1; Two Doses Day 1 + Day 4

Ifosfamide DRUG

2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).

Also known as: Ifex

Single Dose Day 1; Two Doses Day 1 + Day 4

Vincristine DRUG

2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Single Dose Day 1; Two Doses Day 1 + Day 4

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 doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated.
• Must be 18-65 years of age.
• Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
• Adequate hematologic (ANC \>/= 1500/mm\^3, platelet count \>/= 100,000/mm\^3), renal (serum creatinine \</= 1.5 mg/dL), hepatic (serum bilirubin count \</= 1.5 x normal and SGOT or SGPT \</= 3 x normal) functions.
• Karnofsky Performance Status \>/= 60%
• Signed informed consent form.
• Patients are required to read and understand English to comply with protocol requirements.

You may not qualify if:

• Pregnant or lactating women.
• Patients with any co-morbid condition which renders patients at high risk of treatment complication.
• Known allergy to fosaprepitant or any of its active components.
• Patient has uncontrolled angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
• Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
• Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
• Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
• Patients receiving any medication for pre-existing nausea/vomiting will be excluded.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-3722, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma; Vomiting; Neoplasms; Nausea

Interventions

fosaprepitant; Dexamethasone; dexamethasone acetate; Calcium Dobesilate; Doxorubicin; Mesna; Ifosfamide; Vincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

(713) 792-7966

Study Officials

• Saroj Vadhan-Raj, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 11, 2016
• Results First Posted: June 3, 2015

Record last verified: 2016-03

Locations

US (1)