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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)


Phase 2
N/A
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000271889

NCT ID:

NCT00055952

Start Date:

January 2003

Completion Date:

April 2006

Related Keywords:

  • Sarcoma
  • 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
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Desmoplastic Small Round Cell Tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Medical City Dallas HospitalDallas, Texas  75230
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Nemours Children's ClinicJacksonville, Florida  32207
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063