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

This study has been terminated.
(Low accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00673179
First received: May 6, 2008
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Early study termination with low accrual.

Reporting Groups
  Description
Outpatient Chemotherapy 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).
Additional Risk-Adapted Outpatient Chemotherapy 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).

Participant Flow:   Overall Study
    Outpatient Chemotherapy     Additional Risk-Adapted Outpatient Chemotherapy  
STARTED     7     0  
COMPLETED     4     0  
NOT COMPLETED     3     0  
Toxicity/Complications                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Outpatient Chemotherapy 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).
Additional Risk-Adapted Outpatient Chemotherapy 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 Total of all reporting groups

Baseline Measures
    Outpatient Chemotherapy     Additional Risk-Adapted Outpatient Chemotherapy     Total  
Number of Participants  
[units: participants]
  7     0     7  
Age  
[units: years]
Median ( Full Range )
  14  
  ( 11 to 18 )  
   
   
  14  
  ( 11 to 18 )  
Gender  
[units: participants]
     
Female     3         3  
Male     4         4  
Region of Enrollment  
[units: participants]
     
United States     7         7  



  Outcome Measures

1.  Primary:   Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)   [ Time Frame: Baseline to 5 Years ]

2.  Secondary:   Quality of Life (Ped QL) Assessment   [ Time Frame: Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study could not meet accrual goal due to logistical considerations, terminated early.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter M. Anderson, MD, PHD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00673179     History of Changes
Other Study ID Numbers: 2007-0404
Study First Received: May 6, 2008
Results First Received: June 12, 2013
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board