Combination Chemotherapy in Treating Patients With Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00662233
First received: April 18, 2008
Last updated: March 20, 2014
Last verified: March 2014
  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:


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: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Carola A. S. Arndt, MD Mayo Clinic
  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: March 20, 2014
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:
Sarcoma
Ovarian Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
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
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on October 16, 2014