Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor

NCT00055952 | Completed Phase 2

• 3 other identifiers: CDR0000271889DAIICHI-8951A-PRT034SJCRH-DXEWS
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.

Conditions

Sarcoma

Keywords

childhood desmoplastic small round cell tumor; metastatic childhood soft tissue sarcoma; nonmetastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; localized Ewing sarcoma/peripheral primitive neuroectodermal tumor; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Interventions

exatecan mesylate DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * One of the following histologically confirmed diagnoses: * Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor * Desmoplastic small round cell tumor * Measurable disease * The following are not considered measurable disease: * Ascites * Pleural effusion * Lytic bone lesions * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-2 (over 10 years of age) * Lansky 60-100% (10 years of age and under) Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 750/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 8.5 g/dL Hepatic * Bilirubin no greater than 2.0 mg/dL * AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Albumin at least 2.8 g/dL Renal * Creatinine less than 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active serious infection * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No overt psychosis or mental disability that would preclude informed consent * No other life-threatening illness within the past 6 months PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior autologous bone marrow or stem cell transplantation * No concurrent biologic therapy Chemotherapy * Recovered from prior systemic chemotherapy * Prior topoisomerase I inhibitor therapy allowed * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy * More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve * No concurrent radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered * No concurrent surgery Other * More than 28 days since prior investigational drugs (including analgesics or antiemetics) * No more than 2 prior treatment regimens for this disease * No other investigational drugs during and for 28 days after study therapy * No other concurrent anticancer therapy * No concurrent grapefruit or grapefruit juice

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (9)

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80218, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9063, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Sarcoma; Desmoplastic Small Round Cell Tumor; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

exatecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Robert L. DeJager, MD, FACP

  Daiichi Sankyo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: January 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

US (8); CA (1)