Combination Chemotherapy in Treating Patients With Sarcoma
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00662233
First received: April 18, 2008
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer Sarcoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: brachytherapy Radiation: intraoperative radiation therapy Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study for Soft Tissue Sarcoma |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Vincristine sulfate
Ifosfamide
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Efficacy in terms of long-term disease-free survival [ Designated as safety issue: No ]
- Clinical response of the tumors [ Designated as safety issue: No ]
- Pathologic response of the tumors [ Designated as safety issue: No ]
- Long term disease-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 1991 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.
- Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).
- Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.
NOTE: *Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.
- Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.
After completion of treatment, patients are followed periodically for at least 5 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of any of the following:
- High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma)
- Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual)
- Undifferentiated sarcomas (closed to accrual)
- Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual)
- All alveolar rhabdomyosarcomas (closed to accrual)
No evidence distant metastatic disease (i.e., lung, bone, bone marrow)
- Local or regional nodal disease allowed
- No spindle cell tumors of bone
- Primary lesions do not have to be resectable
PATIENT CHARACTERISTICS:
- Creatinine ≤1.5 mg/dL OR creatinine clearance > 60 mL/min/
- AST/ALT < 2 times upper limit of normal (ULN)
- Total bilirubin < 2 times ULN
- LVEF ≥ 45%
- No prior history of cancer
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy
- No prior chemotherapy
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Carola A. S. Arndt, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00662233 History of Changes |
| Other Study ID Numbers: | CDR0000582271, P30CA015083, 919110, 542-91, 0791 |
| Study First Received: | April 18, 2008 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
alveolar childhood rhabdomyosarcoma previously treated childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma nonmetastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma |
childhood desmoplastic small round cell tumor ovarian sarcoma stage II uterine sarcoma stage III uterine sarcoma embryonal childhood rhabdomyosarcoma |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Sarcoma Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Cyclophosphamide |
Ifosfamide Isophosphamide mustard Doxorubicin Etoposide Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013