Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Amgen
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00267046

Purpose

Primary:

To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy.
To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.

Exploratory:

To evaluate the biologic effect of palifermin on oral mucosa.
To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.

Condition	Intervention	Phase
Sarcoma Oral Mucositis	Drug: Palifermin Drug: Placebo Drug: Doxorubicin Drug: Ifosfamide Drug: Vincristine Drug: Cisplatin	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Vincristine Cisplatin Doxorubicin Doxorubicin hydrochloride Myocet Palifermin Vincristine sulfate Ifosfamide

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Efficacy [ Time Frame: 18 weeks (about 4 to 5 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence and severity of oral mucositis [ Time Frame: Every 3 weeks for about 4 to 5 months during the treatment period ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	December 2005
Study Completion Date:	July 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Palifermin + Chemotherapy (AI Regimen)	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).
2: Placebo Comparator Placebo + Chemotherapy (AI Regimen)	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).
3: Experimental Palifermin + Chemotherapy (AP Regimen)	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.
4: Placebo Comparator Placebo + Chemotherapy (AP Regimen)	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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Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (90 mg/m2) with ifosfamide (AI) or cisplatinum (AP) is indicated.
Must be >/= 16 and </= 65 years of age.
Patients (male and female) with childbearing potential (defined as not post-menopausal for 12 months, negative blood pregnancy test, or no previous surgical sterilization) must use adequate birth control.
Adequate hematologic (ANC >/= 1500/mm^3, >/= Hgb 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5mg/dL), hepatic (serum bilirubin count </= 1.5 x normal and SGPT < 3 x 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 metastatic disease to CNS.
Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia, acute myocardial infarction within 3 months or has uncontrolled hypertension.
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.
Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2).
Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is to obtain post-treatment data on the subject (eg, long-term follow-up or survival data).
Known sensitivity to any of the products to be administered during this study, including Escherichia coli-derived products.
Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
Patients with a history of pancreatitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267046

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Amgen

Investigators

Principal Investigator:

Saroj Vadhan-Raj, M.D.

University of Texas MDAnderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor )
Study ID Numbers:	2004-0511
Study First Received:	December 19, 2005
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00267046 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Sarcoma
Soft Tissue Sarcoma
Oral Mucositis
Doxorubicin
Adriamycin

Ifosfamide
Palifermin
Vincristine
Cisplatin
Placebo

Additional relevant MeSH terms:

Mouth Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Cisplatin
Therapeutic Uses
Alkylating Agents
Neoplasms by Histologic Type
Stomatitis
Mucositis
Mitosis Modulators
Vincristine

Antimitotic Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Ifosfamide
Digestive System Diseases
Radiation-Sensitizing Agents
Tubulin Modulators
Sarcoma
Stomatognathic Diseases
Antineoplastic Agents, Alkylating
Gastroenteritis
Antineoplastic Agents, Phytogenic
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 25, 2009