A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
N/A
N/A
Both
Sarcoma
Trial Information
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
OBJECTIVES:
- Determine the objective response rate (complete and partial responses) in pediatric
patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival and survival at 6 and 12 months in patients treated with
this drug.
- Assess pain in patients treated with this drug.
- Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
- Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3
weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent or resistant rhabdomyosarcoma
- 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 old)
- Lansky 60-100% (10 years old 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
- Albumin at least 2.8 g/dL
- AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if
liver metastases present)
Renal
- Creatinine no greater than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No life threatening illness (unrelated to tumor) within the past 6 months
- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
- No concurrent active serious infection
- No concurrent uncontrolled infection
- No overt psychosis or other incompetency that would preclude study compliance or
giving informed consent
- No other concurrent noncancer-related illness that would preclude study participation
or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior autologous bone marrow or stem cell transplantation
- No concurrent anticancer biologic therapy
Chemotherapy
- Recovered from prior adjuvant or systemic chemotherapy
- Prior topoisomerase I inhibitor therapy allowed
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis,
whole pelvis, or 25% of marrow reserve
- No concurrent anticancer radiotherapy
Surgery
- At least 4 weeks since prior major surgery
- Recovered from prior surgery
- No concurrent anticancer surgery
Other
- At least 28 days since prior investigational drugs (including analgesics or
antiemetics)
- No more than 2 prior regimens for rhabdomyosarcoma
- No concurrent grapefruit-containing beverages or foods
- No other concurrent investigational drugs during and for 28 days after final dose of
study drug
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, 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:
CDR0000271888
NCT ID:
NCT00055939
Start Date:
January 2003
Completion Date:
April 2006
Related Keywords:
- Sarcoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- Rhabdomyosarcoma
- Sarcoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
