Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00645632
First received: March 26, 2008
Last updated: May 13, 2011
Last verified: May 2011
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Purpose
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.
| Condition | Intervention |
|---|---|
|
Sarcoma |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: methotrexate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Treatment of Newly Diagnosed Untreated Osteosarcoma: A Pilot Study of a New Chemotherapeutic Regimen Including Ifosfamide |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Ifosfamide
Methotrexate sodium
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Histopathologic response rate [ Designated as safety issue: No ]
- Clinical response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 1990 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 1995 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To evaluate the efficacy of a new induction regimen comprising ifosfamide in combination with high-dose methotrexate, cisplatin, and doxorubicin hydrochloride, in terms of clinical response and pathological response of the tumor, in patients with newly diagnosed high-grade osteosarcoma.
- To determine the overall survival and disease-free survival of these patients.
- To evaluate the toxicity of this regimen.
- To correlate MRI imaging of the primary tumor with histopathologic grading after treatment with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemotherapy (weeks 1-15): Patients receive ifosfamide IV over 1 hour on days 1-5 and 36-40; doxorubicin hydrochloride IV over 18 hours on days 1-3 and 36-38 and IV over 72 hours on days 71-73; high-dose methotrexate IV over 4 hours on days 22, 29, 57, 64, 92, and 99; and cisplatin IV over 4 hours on day 71.
- Surgery (week 16): Patients undergo resection of the tumor on day 106. Patients found to have unresectable disease are treated on an alternative protocol unless they have clear clinical and pathologic response to treatment.
- Adjuvant chemotherapy (weeks 18-43): Beginning 2 weeks after surgery, patients receive ifosfamide IV over 1 hour on days 120-124, 155-159, 225-229, and 260-264; doxorubicin hydrochloride IV over 18 hours on days 120-122 and 155-157 and IV over 72 hours on days 190-192; high-dose methotrexate IV over 4 hours on days 141, 148, 176, 183, 211, 218, 246, 253, 281, and 288; and cisplatin IV over 4 hours on days 190 and 289.
After completion of study therapy, patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed osteosarcoma of the extremity
High-grade (grade III or IV) disease
- No low-grade disease (e.g., parosteal or periosteal osteosarcoma)
- No secondary osteosarcoma (i.e., tumor occurring in a radiotherapy field designed for a prior tumor)
- No Paget's disease
- No known metastases
PATIENT CHARACTERISTICS:
- Total bilirubin < 2 times normal
- AST < 2 times normal
- Alkaline phosphatase < 2 times normal
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min
- LVEF ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No other prior malignancy except retinoblastoma
- Patients with familial retinoblastoma syndrome who develop osteosarcoma unrelated to radiotherapy (e.g., in a primary site in the extremities) are eligible
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy
- Patients with retinoblastoma may have received radiotherapy to the orbits
- At least 28 days since prior initial amputation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645632
Sponsors and Collaborators
Mayo Clinic
Investigators
| Study Chair: | Gerald S. Gilchrist, MD | Mayo Clinic |
| Principal Investigator: | Tom R Fitch, M.D. | Mayo Clinic |
| Principal Investigator: | Gerardo Colon-Otero, M.D. | Mayo Clinic Florida |
More Information
Additional Information:
No publications provided
| Responsible Party: | Carola A.S. Arndt, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00645632 History of Changes |
| Other Study ID Numbers: | CDR0000582263, P30CA015083, 909101, 549-90 |
| Study First Received: | March 26, 2008 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
localized osteosarcoma |
Additional relevant MeSH terms:
|
Osteosarcoma Sarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Isophosphamide mustard Cisplatin Doxorubicin Ifosfamide Methotrexate Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013