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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00055952

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: exatecan mesylate	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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