Combination Chemotherapy in Treating Patients With Sarcoma - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00662233

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

MedlinePlus related topics: Cancer Ovarian Cancer Radiation Therapy Soft Tissue Sarcoma

Drug Information available for: Cyclophosphamide Vincristine Doxorubicin Doxorubicin hydrochloride Etoposide Myocet Vincristine sulfate Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study for Soft Tissue Sarcoma

Further study details as provided by National Cancer Institute (NCI):

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:	July 2008 (Final data collection date for primary outcome measure)

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662233

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Carola A. S. Arndt, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000582271, MAYO-919110
Study First Received:	April 18, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00662233 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Desmoplastic Small Round Cell Tumor
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Etoposide phosphate
Genital Diseases, Female
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Ovarian Cancer
Alkylating Agents
Etoposide
Endocrine Gland Neoplasms

Rhabdomyosarcoma
Ovarian Neoplasms
Adjuvants, Immunologic
Genital Neoplasms, Female
Endocrine System Diseases
Vincristine
Rhabdomyosarcoma, Childhood
Antimitotic Agents
Immunosuppressive Agents
Recurrence
Doxorubicin
Malignant Mesenchymal Tumor
Ifosfamide
Uterine Sarcoma
Tubulin Modulators

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Endocrine Gland Neoplasms

Ovarian Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Ifosfamide
Tubulin Modulators
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 07, 2009