Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019864
First received: July 11, 2001
Last updated: May 9, 2009
Last verified: October 2007
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy before and after surgery works in treating patients with osteosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Toxicity Sarcoma |
Biological: filgrastim Drug: cisplatin Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma. |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Leucovorin calcium
Methotrexate sodium
Cisplatin
Doxorubicin
Dexrazoxane
Doxorubicin hydrochloride
Levoleucovorin
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Dexrazoxane hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Rate of in vivo histologic response [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2000 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the rate of in vivo histologic response in patients with osteosarcoma treated with neoadjuvant cisplatin, methotrexate, and doxorubicin with dexrazoxane (as cardioprotection).
- Determine the event-free and overall survival of patients with nonmetastatic disease who show good response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.
- Determine the event-free survival of patients with nonmetastatic disease who show poor response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.
- Determine the event-free survival and overall survival of patients with metastatic disease who receive neoadjuvant therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive neoadjuvant chemotherapy comprising dexrazoxane IV over 15 minutes, doxorubicin IV over 15 minutes, and cisplatin IV over 4 hours on days 1 and 2 in week 0. Patients also receive methotrexate IV over 4 hours followed by leucovorin calcium in weeks 3 and 4. Patients then receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Surgical resection: Patients undergo definitive surgery in week 11.
- Adjuvant therapy: Patients receive dexrazoxane, doxorubicin, cisplatin, methotrexate, and leucovorin calcium as in neoadjuvant therapy*. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Cisplatin is not administered in courses 3 and 4 of adjuvant therapy
Patients are followed within 4 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed osteosarcoma
- No more than 1 month since prior diagnostic biopsy
- Nonmetastatic malignant high-grade osteosarcoma of bone
- Histologically confirmed metastatic disease allowed
- Unresectable primary disease allowed
- No low-grade, parosteal, or periosteal osteosarcoma
PATIENT CHARACTERISTICS:
Age:
- 25 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT less than 5 times normal
Renal:
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min
Cardiovascular:
- Shortening fraction at least 27% by echocardiogram or MUGA
- Ejection fraction at least 45% by echocardiogram or MUGA
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- No other concurrent therapy with no evidence of progressive disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019864
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Texas | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
| Houston, Texas, United States, 77030-2399 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Ramzi Dagher, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00019864 History of Changes |
| Obsolete Identifiers: | NCT00001821 |
| Other Study ID Numbers: | CDR0000067263, NCI-99-C-0125I |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cardiac toxicity localized osteosarcoma metastatic osteosarcoma recurrent osteosarcoma |
Additional relevant MeSH terms:
|
Osteosarcoma Sarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Cisplatin Doxorubicin Methotrexate Razoxane Leucovorin Levoleucovorin Lenograstim Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 16, 2013