Combination Chemotherapy in Treating Patients With Sarcoma

Ovarian Cancer Clinical Trial

Official title:

A Pilot Study for Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662233
• Other study ID #: CDR0000582271
• Secondary ID: P30CA01508391911
• Status: Completed
• Phase: Early Phase 1
• Start date: October 1991
• Est. completion date: October 21, 2013

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 21, 2013
• Est. primary completion date: October 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Sarcoma

Intervention

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• ifosfamide

• vincristine sulfate

Procedure:
• adjuvant therapy

• neoadjuvant therapy

• therapeutic conventional surgery

Radiation:
• brachytherapy

• intraoperative radiation therapy

• radiation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in terms of long-term disease-free survival
Primary	Clinical response of the tumors
Primary	Pathologic response of the tumors
Primary	Long term disease-free survival