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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055952

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: exatecan mesylate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Exatecan Exatecan mesylate

U.S. FDA Resources

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

Study Start Date:

January 2003

Detailed Description:

OBJECTIVES:

Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate.
Determine the time to tumor progression in patients treated with this drug.
Determine median survival and 6- and 12-month survival of patients treated with this drug.
Determine the pain response in patients treated with this drug.
Determine the qualitative and quantitative toxic effects of this drug in these patients.
Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor).

Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer).

Patients are followed every 3 months for 1 year after withdrawal from study.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055952

Locations

United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Chair:

Robert L. DeJager, MD, FACP

Daiichi Sankyo Inc.

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:	CDR0000271889, DAIICHI-8951A-PRT034, SJCRH-DXEWS
Study First Received:	March 6, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00055952 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Desmoplastic Small Round Cell Tumor
Neuroectodermal Tumors, Primitive
Osteosarcoma
DX 8951
Ewing's Sarcoma
Camptothecin
Recurrence
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Malignant Mesenchymal Tumor

Soft Tissue Sarcomas
Neoplasms, Germ Cell and Embryonal
Peripheral Neuroectodermal Tumor
Sarcoma
Osteogenic Sarcoma
Neuroepithelioma
Ewing's Family of Tumors
Antineoplastic Agents, Phytogenic
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Osteosarcoma
Enzyme Inhibitors
DX 8951
Pharmacologic Actions
Camptothecin
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors

Sarcoma, Ewing's
Neoplasms
Neoplasms, Bone Tissue
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009