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

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

Interventions

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.

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.

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.

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.

BEHAVIORAL

Questionnaire

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

DRUG

Gemcitabine

IV over 1 hour, every other week.

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.

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Peter M. Anderson, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• United States

Study Locations