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Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
This study has been completed.
Sponsor:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00055939
First received: March 6, 2003
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Sarcoma | Drug: exatecan mesylate | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
| Study Start Date: | January 2003 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055939
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055939
Locations
| 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 | |
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
| Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
More Information
| Responsible Party: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00055939 History of Changes |
| Other Study ID Numbers: |
CDR0000271888 DAIICHI-8951A-PRT033 SJCRH-DXRMS |
| Study First Received: | March 6, 2003 |
| Last Updated: | May 15, 2012 |
Keywords provided by Daiichi Sankyo Inc.:
|
previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma |
Additional relevant MeSH terms:
|
Rhabdomyosarcoma Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Exatecan |
Camptothecin Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on July 27, 2017