Trial Outcomes & Findings for Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy (NCT NCT00673179)
NCT ID: NCT00673179
Last Updated: 2014-09-10
Results Overview
Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline to 5 Years
Results posted on
2014-09-10
Participant Flow
Recruitment period: May 05, 2008 to November 24, 2010. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
Early study termination with low accrual.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Toxicity/Complications
|
3
|
0
|
Baseline Characteristics
Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
Baseline characteristics by cohort
| Measure |
Outpatient Chemotherapy
n=7 Participants
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
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
n=99 Participants
|
—
|
14 years
n=206 Participants
|
|
Gender
Female
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
|
Gender
Male
|
4 participants
n=99 Participants
|
—
|
4 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
—
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 YearsPopulation: Study terminated early without analysis.
Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.Outcome measures
Outcome data not reported
Adverse Events
Outpatient Chemotherapy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Additional Risk-Adapted Outpatient Chemotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Outpatient Chemotherapy
n=7 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Adverse event reporting up to 39 weeks of varying treatment, with overall study 2 years, 2 months.
Expected toxicities for these varieties of osteosarcoma chemotherapy.
|
—
0/0 • Adverse event reporting up to 39 weeks of varying treatment, with overall study 2 years, 2 months.
Expected toxicities for these varieties of osteosarcoma chemotherapy.
|
Other adverse events
| Measure |
Outpatient Chemotherapy
n=7 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Adverse event reporting up to 39 weeks of varying treatment, with overall study 2 years, 2 months.
Expected toxicities for these varieties of osteosarcoma chemotherapy.
|
—
0/0 • Adverse event reporting up to 39 weeks of varying treatment, with overall study 2 years, 2 months.
Expected toxicities for these varieties of osteosarcoma chemotherapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place