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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00055952 |
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Date of registration:
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06/03/2003 |
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Primary sponsor: |
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Public title:
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Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
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Scientific title:
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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) |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00055952 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Robert L. DeJager, MD, FACP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Daiichi Sankyo Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sarcoma
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Intervention(s)
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Drug: exatecan mesylate
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Secondary ID(s)
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CDR0000271889
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DAIICHI-8951A-PRT034
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SJCRH-DXEWS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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