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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00077285
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.


Condition Intervention Phase
Sarcoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: ifosfamide
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide Cyclophosphamide Carboplatin Filgrastim Etoposide Vincristine sulfate Vincristine Irinotecan Irinotecan hydrochloride Etoposide phosphate Dexrazoxane Dexrazoxane hydrochloride ICRF 159 Razoxane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma

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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Safety and feasibility [ Designated as safety issue: Yes ]
  • Rate of local control [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome [ Designated as safety issue: No ]
  • Efficacy in terms of improved outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: October 2003
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed rhabdomyosarcoma (RMS), undifferentiated sarcoma, or ectomesenchymoma, meeting criteria for 1 of the following:

    • High-risk disease

      • Distant metastases (stage 4, group IV)
    • Intermediate-risk disease

      • Nonmetastatic undifferentiated sarcoma OR alveolar RMS OR ectomesenchymoma with alveolar features (regardless of age, site, size, stage, or degree of initial surgical resection)
      • Stage 2 or 3, group III embryonal RMS OR ectomesenchymoma with embryonal features
  • Newly diagnosed

    • Previously untreated
  • Biopsy or definitive surgery required within the past 42 days

PATIENT CHARACTERISTICS:

Age

  • 30 and under at diagnosis

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3*
  • Hemoglobin ≥ 9 g/dL*
  • Platelet count ≥ 100,000/mm^3* NOTE: *Unless there is bone marrow infiltration by tumor or presence of disseminated intravascular coagulation

Hepatic

  • Bilirubin < 2.5 times upper limit of normal (ULN)*
  • SGOT and SGPT < 2.5 times ULN* NOTE: *Unless there is hepatic involvement by tumor

Renal

  • Creatinine normal for age OR
  • Creatinine clearance or nuclear glomerular filtration rate at least 80 mL/min (in the absence of obstructive hydronephrosis)

Cardiovascular

  • Shortening fraction ≥ 28% by echocardiogram OR
  • LVEF ≥ 50% by MUGA

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior steroids allowed

Radiotherapy

  • No prior radiotherapy, except limited, emergent radiotherapy (e.g., treatment of threatened airway or spinal cord compromise)

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077285

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Leonard H. Wexler, MD     212-639-7990     wexlerl@mskcc.org    
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard H. Wexler, MD Memorial Sloan-Kettering Cancer Center
  More Information

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

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Leonard H. Wexler )
Study ID Numbers: CDR0000350083, MSKCC-03099
Study First Received: February 10, 2004
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00077285  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
previously untreated childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
adult rhabdomyosarcoma
stage IV adult soft tissue sarcoma
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
childhood malignant mesenchymoma
adult malignant mesenchymoma
stage III adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage I adult soft tissue sarcoma

Study placed in the following topic categories:
Malignant mesenchymal tumor
Irinotecan
Vincristine
Carboplatin
Cyclophosphamide
Etoposide phosphate
Camptothecin
Soft tissue sarcomas
Doxorubicin
Razoxane
Neoplasms, Connective and Soft Tissue
Ifosfamide
Sarcoma
Etoposide
Rhabdomyosarcoma
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myosarcoma
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Cardiovascular Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Chelating Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009