Combination Chemotherapy in Treating Patients With Sarcoma

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00662233

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

264.7

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
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	Early Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Primary Purpose:

Treatment

Official Title:

A Pilot Study for Soft Tissue Sarcoma

Actual Study Start Date :

Oct 1, 1991

Actual Primary Completion Date :

Oct 21, 2013

Actual Study Completion Date :

Oct 21, 2013

Outcome Measures

Primary Outcome Measures

Efficacy in terms of long-term disease-free survival []
Clinical response of the tumors []
Pathologic response of the tumors []
Long term disease-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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