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

NCT00673179 | Terminated Results

• 1 other identifier: 2007-0404
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma

Keywords

Doxorubicin; AD; Hydroxydaunomycin hydrochloride; Cisplatin; Paraplatin®; Methotrexate; Ifosfamide; Osteosarcoma; Sargramostim; Leukine™; Leucovorin; Gemcitabine; Gemzar; Gemcitabine Hydrochloride; GM-CSF; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)

  Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.

  Baseline to 5 Years

Secondary Outcomes (1)

• Quality of Life (Ped QL) Assessment

  Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.

Study Arms (2)

Outpatient Chemotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Methotrexate; Drug: Leucovorin; Behavioral: Questionnaire; Procedure: Surgery

Additional Risk-Adapted Outpatient Chemotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Methotrexate; Drug: Leucovorin; Drug: Dexrazoxane; Drug: Ifosfamide; Behavioral: Questionnaire; Drug: Gemcitabine; Drug: Sargramostim; Procedure: Surgery; Drug: Mesna

Interventions

Doxorubicin DRUG

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.

Also known as: AD, Hydroxydaunomycin hydrochloride

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Cisplatin DRUG

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.

Also known as: Paraplatin®

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Methotrexate DRUG

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.

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Leucovorin DRUG

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.

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Dexrazoxane DRUG

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.

Also known as: Zinecard

Additional Risk-Adapted Outpatient Chemotherapy

Ifosfamide DRUG

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.

Also known as: Ifex

Additional Risk-Adapted Outpatient Chemotherapy

Questionnaire BEHAVIORAL

Questionnaires to be completed on 5 different days during the study.

Also known as: Survey

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Gemcitabine DRUG

IV over 1 hour, every other week.

Also known as: Gemzar, Gemcitabine Hydrochloride

Additional Risk-Adapted Outpatient Chemotherapy

Sargramostim DRUG

Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg) twice a day for 7 days on, 7 days off, beginning the day receive gemcitabine.

Also known as: GM-CSF, Leukine™

Additional Risk-Adapted Outpatient Chemotherapy

Surgery PROCEDURE

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

Additional Risk-Adapted Outpatient Chemotherapy; Outpatient Chemotherapy

Mesna DRUG

IV continuously over 6 days each time, on Weeks 16, 22, 28, and 34. Dose 2.8 gm/m\^2/day.

Also known as: Mesnex

Additional Risk-Adapted Outpatient Chemotherapy

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.
• Age 5-40 years old on date of diagnostic biopsy.
• 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.
• Signed informed consent.
• Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Osteosarcoma

Interventions

Doxorubicin; Cisplatin; Carboplatin; Methotrexate; Leucovorin; Dexrazoxane; Ifosfamide; Surveys and Questionnaires; Gemcitabine; sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Surgical Procedures, Operative; Mesna

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Limitations and Caveats

Study could not meet accrual goal due to logistical considerations, terminated early.

Results Point of Contact

• Title: Peter M. Anderson, MD, PHD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Peter M. Anderson, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 10, 2014
• Results First Posted: September 10, 2014

Record last verified: 2014-09

Locations

US (1)