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Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00267046
First received: December 19, 2005
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

Primary:

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

Exploratory:

  1. To evaluate the biologic effect of palifermin on oral mucosa.
  2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
  3. 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: Adriamycin (Doxorubicin)
Drug: Ifosfamide
Drug: Vincristine
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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:


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

Primary Outcome Measures:
  • Cumulative Incidence Rate of Oral Mucositis [ Time Frame: Within 6 blinded cycles (3-week cycles), up to 18 weeks. ] [ Designated as safety issue: No ]

    Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.

    WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible.


  • Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles [ Time Frame: Within the first 2 blinded cycles (3-week cycles), up to 6 weeks. ] [ Designated as safety issue: No ]
    Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).


Enrollment: 49
Study Start Date: December 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palifermin

Palifermin + Chemotherapy (Adriamycin (Doxorubicin)+ Ifosfamide (AI) or Adriamycin (Doxorubicin) + Cisplatin (AP) Regimen); Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.

AP=Doxorubicin (Adriamycin) + Cisplatin:

Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0.

Drug: Palifermin
180 mcg/kg 3 days prior to chemotherapy
Drug: Adriamycin (Doxorubicin)
30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Other Name: Adriamycin
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 on day 0, for patients with small cell histology receiving the AI Regimen.
Drug: Cisplatin
120 mg/m^2 on day 0, for patients receiving the AP Regimen.
Other Names:
  • CDDP
  • Platinol
Placebo Comparator: Placebo

Placebo + Chemotherapy (AI or AP Regimen);

AI = Doxorubicin (Adriamycin) + Ifosfamide:

A single dose placebo prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.

AP=Doxorubicin (Adriamycin) + Cisplatin:

A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0.

Drug: Placebo
Single dose 3 days prior to chemotherapy
Drug: Adriamycin (Doxorubicin)
30 mg/m^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m^2).
Other Name: Adriamycin
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 on day 0, for patients with small cell histology receiving the AI Regimen.
Drug: Cisplatin
120 mg/m^2 on day 0, for patients receiving the AP Regimen.
Other Names:
  • CDDP
  • Platinol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Adequate hematologic (Absolute neutrophil count (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 * normal and SGPT < 3 * normal) functions.
  4. Karnofsky Performance Status >/= 80.
  5. Signed informed consent form.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with comorbid condition which renders patients at high risk of treatment complication.
  3. Patients with metastatic disease to CNS.
  4. 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.
  5. 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.
  6. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
  7. Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2).
  8. 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).
  9. Known sensitivity to any of the products to be administered during this study, including Escherichia coli-derived products.
  10. Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
  11. Patients with a history of pancreatitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Saroj Vadhan-Raj, M.D. University of Texas MDAnderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00267046     History of Changes
Other Study ID Numbers: 2004-0511
Study First Received: December 19, 2005
Results First Received: January 18, 2012
Last Updated: April 17, 2012
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:
Mucositis
Sarcoma
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Stomatognathic Diseases
Cisplatin
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Vincristine
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014