Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00055939 |
Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : May 16, 2012
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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 children who have relapsed or refractory rhabdomyosarcoma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: exatecan mesylate | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
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 Patients With Relapsed Or Refractory Rhabdomyosarcoma |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2006 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055939
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 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo, Inc. |
Responsible Party: | Daiichi Sankyo, Inc. |
ClinicalTrials.gov Identifier: | NCT00055939 |
Other Study ID Numbers: |
CDR0000271888 DAIICHI-8951A-PRT033 SJCRH-DXRMS |
First Posted: | March 7, 2003 Key Record Dates |
Last Update Posted: | May 16, 2012 |
Last Verified: | May 2012 |
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