SarcomaPhase 2NCT00055939
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
A Phase 2 study testing exatecan mesylate in people with Sarcoma, run by Daiichi Sankyo at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- exatecan mesylate
- How many people
- Not given
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2003to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Medical City Dallas Hospital
Dallas, Texas, 75230
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9063
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80218
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Nemours Children's Clinic
Jacksonville, Florida, 32207
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
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
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.
Read the detailed description
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.
- Conditions
- Sarcoma
- Being tested
- exatecan mesylate
- Keywords
- previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exatecan mesylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startJan 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert L. DeJager, MD, FACP, Study chair, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055939
- Sponsor's protocol ID
- CDR0000271888
- Other IDs
- DAIICHI-8951A-PRT033, SJCRH-DXRMS
- Status last verified
- May 2012
- First submitted
- 6 Mar 2003
- Last updated
- 16 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00055939
- Acronym / sponsor ID
- CDR0000271888
- Conditions
- Sarcoma
- Keywords
- previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exatecan mesylate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L. DeJager, MD, FACP study chair
Daiichi Sankyo
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exatecan mesylate in people with Sarcoma, run by Daiichi Sankyo at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.