Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Pediatric Osteosarcoma" | "Alkylating Agents"
Previous Study | Return to List | Next Study

Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673179
Recruitment Status : Terminated (Low accrual.)
First Posted : May 7, 2008
Results First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteosarcoma
Interventions Drug: Doxorubicin
Drug: Cisplatin
Drug: Methotrexate
Drug: Leucovorin
Drug: Dexrazoxane
Drug: Ifosfamide
Behavioral: Questionnaire
Drug: Gemcitabine
Drug: Sargramostim
Procedure: Surgery
Drug: Mesna
Enrollment 7
Recruitment Details Recruitment period: May 05, 2008 to November 24, 2010. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Early study termination with low accrual.
Arm/Group Title Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Hide Arm/Group Description Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg). Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
Period Title: Overall Study
Started 7 0
Completed 4 0
Not Completed 3 0
Reason Not Completed
Toxicity/Complications             3             0
Arm/Group Title Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy Total
Hide Arm/Group Description Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg). Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg). Total of all reporting groups
Overall Number of Baseline Participants 7 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 0 participants 7 participants
14
(11 to 18)
14
(11 to 18)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 7 participants
Female 3 3
Male 4 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 0 participants 7 participants
7 7
1.Primary Outcome
Title Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)
Hide Description Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.
Time Frame Baseline to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early without analysis.
Arm/Group Title Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Hide Arm/Group Description:
Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quality of Life (Ped QL) Assessment
Hide Description [Not Specified]
Time Frame Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.
Outcome Measure Data Not Reported
Time Frame Adverse event reporting up to 39 weeks of varying treatment, with overall study 2 years, 2 months.
Adverse Event Reporting Description Expected toxicities for these varieties of osteosarcoma chemotherapy.
 
Arm/Group Title Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Hide Arm/Group Description Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg). Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
All-Cause Mortality
Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   0/0 
Skin and subcutaneous tissue disorders     
Rash  1 [1]  1/7 (14.29%)  0/0 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Outpatient Chemotherapy Additional Risk-Adapted Outpatient Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   0/0 
Skin and subcutaneous tissue disorders     
Rash  1 [1]  1/7 (14.29%)  0/0 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 2
Study could not meet accrual goal due to logistical considerations, terminated early.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter M. Anderson, MD, PHD / Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00673179     History of Changes
Other Study ID Numbers: 2007-0404
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: June 12, 2013
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014