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

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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

Brief Summary:
The goal of this clinical research study is to learn if giving certain combinations of chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs and schedules will vary depending on the status of the cancer and its level of risk for spreading, but they will include combinations of doxorubicin (non-liposomal), cisplatin, methotrexate, and ifosfamide, as described below.

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Doxorubicin Drug: Cisplatin Drug: Methotrexate Drug: Leucovorin Drug: Dexrazoxane Drug: Ifosfamide Behavioral: Questionnaire Drug: Gemcitabine Drug: Sargramostim Procedure: Surgery Drug: Mesna Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Chemotherapy in Pediatric Osteosarcoma: Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
Study Start Date : May 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010


Arm Intervention/treatment
Experimental: Outpatient Chemotherapy
Pre-Surgery, Regimen 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 1: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue.
Drug: Doxorubicin
Pre-Surgery, Regimen 1: IV Over 15 Minutes on Day 1 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV on Day 1 of Weeks 16, 21, and 26; Pre-Surgery, Regimen 2: IV over 15 Minutes on Day 1 of Weeks 1, 4, and 7. Dose 90 mg/m^2.
Other Names:
  • AD
  • Hydroxydaunomycin hydrochloride

Drug: Cisplatin
Pre-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 16, 21, and 26. Pre-Surgery, Regimen 2: Infusion through an artery over 4 hours on Day 1 of Weeks 1, 4, and 7. Dose 60 mg/m^2/day for 2 days continuous infusion.
Other Name: Paraplatin®

Drug: Methotrexate
Pre-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 4, 5, 9, and 10; Post-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 14, 15, 19, 20, 24, 25, 29, and 30; Post-Surgery, Regimen 2: IV Over 4 Hours on Day 1 of Weeks 14, 15, 20, 21, 26, 27, 32, 33, 38, and 39. Dose 12 gm/m^2, max 20 gm over 4 hours.

Drug: Leucovorin
Pre- and Post-Surgery, Regimen 1: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours; Post-Surgery, Regimen 2: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours. Dose 10 mg IV, with 10 mg orally every 6 hours.

Behavioral: Questionnaire
Questionnaires to be completed on 5 different days during the study.
Other Name: Survey

Procedure: Surgery
Planned limb salvage surgery after 3 courses of doxorubicin + cisplatin (IV) and High-dose methotrexate - at approximately week 12.

Experimental: Additional Risk-Adapted Outpatient Chemotherapy
Pre-Surgery, Regimen 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, Regimen 2: 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).
Drug: Doxorubicin
Pre-Surgery, Regimen 1: IV Over 15 Minutes on Day 1 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV on Day 1 of Weeks 16, 21, and 26; Pre-Surgery, Regimen 2: IV over 15 Minutes on Day 1 of Weeks 1, 4, and 7. Dose 90 mg/m^2.
Other Names:
  • AD
  • Hydroxydaunomycin hydrochloride

Drug: Cisplatin
Pre-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 1 and 6; Post-Surgery, Regimen 1: IV Over 48 Hours, on Days 1 and 2 of Weeks 16, 21, and 26. Pre-Surgery, Regimen 2: Infusion through an artery over 4 hours on Day 1 of Weeks 1, 4, and 7. Dose 60 mg/m^2/day for 2 days continuous infusion.
Other Name: Paraplatin®

Drug: Methotrexate
Pre-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 4, 5, 9, and 10; Post-Surgery, Regimen 1: IV Over 4 Hours on Day 1 of Weeks 14, 15, 19, 20, 24, 25, 29, and 30; Post-Surgery, Regimen 2: IV Over 4 Hours on Day 1 of Weeks 14, 15, 20, 21, 26, 27, 32, 33, 38, and 39. Dose 12 gm/m^2, max 20 gm over 4 hours.

Drug: Leucovorin
Pre- and Post-Surgery, Regimen 1: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours; Post-Surgery, Regimen 2: IV Over 5 minutes on the day after each methotrexate dose and then by mouth every 6 hours. Dose 10 mg IV, with 10 mg orally every 6 hours.

Drug: Dexrazoxane
Dose 900 mg/m^2 IV Push with doxorubicin. Pre-Surgery, Regimen 2: IV Over 15 minutes on Day 1 of Weeks 1, 4, and 7.
Other Name: Zinecard

Drug: Ifosfamide
Post-Surgery, Regimen 2: IV continuously over 5 days each time, on Weeks 16, 22, 28, and 34. Dose 2.8 gm/m^2. Dose 2.8 grams m^2/day.
Other Name: Ifex

Behavioral: Questionnaire
Questionnaires to be completed on 5 different days during the study.
Other Name: Survey

Drug: Gemcitabine
IV over 1 hour, every other week.
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride

Drug: Sargramostim
Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg) twice a day for 7 days on, 7 days off, beginning the day receive gemcitabine.
Other Names:
  • GM-CSF
  • Leukine™

Procedure: Surgery
Planned limb salvage surgery after 3 courses of doxorubicin + cisplatin (IV) and High-dose methotrexate - at approximately week 12.

Drug: Mesna
IV continuously over 6 days each time, on Weeks 16, 22, 28, and 34. Dose 2.8 gm/m^2/day.
Other Name: Mesnex




Primary Outcome Measures :
  1. Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy) [ Time Frame: Baseline to 5 Years ]
    Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.


Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.
  2. Age 5-40 years old on date of diagnostic biopsy.
  3. Adequate organ function: creatinine 1.6 or lower, bilirubin <2, Hemoglobin 8 gm/dL or greater, Absolute neutrophil count (ANC) 1000 or more, platelets 100,000 or more. Cardiac ejection fraction (EF) 50% or better, hearing threshold 40 dB at 4000 Hz or better.
  4. Signed informed consent.
  5. Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.

Exclusion Criteria:

  1. Diagnosis other than osteosarcoma.
  2. Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673179


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Peter M. Anderson, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00673179     History of Changes
Other Study ID Numbers: 2007-0404
First Posted: May 7, 2008    Key Record Dates
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by M.D. Anderson Cancer Center:
Doxorubicin
AD
Hydroxydaunomycin hydrochloride
Cisplatin
Paraplatin®
Methotrexate
Ifosfamide
Osteosarcoma
Sargramostim
Leukine™
Leucovorin
Gemcitabine
Gemzar
Gemcitabine Hydrochloride
GM-CSF
Questionnaire
Survey

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Gemcitabine
Liposomal doxorubicin
Isophosphamide mustard
Cisplatin
Doxorubicin
Methotrexate
Ifosfamide
Carboplatin
Dexrazoxane
Razoxane
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors