- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00509860
Irinotecan (Camptosar) in Patients With Advanced Sarcomas
A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas
Primary Objectives:
- To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma.
- To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population.
Study Overview
Detailed Description
Irinotecan is a chemotherapy drug that fights cancer by interfering with the cancer cells' ability to divide and grow.
Before treatment starts, you will be asked questions about your health and have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have computed tomography (CT) scans and x-rays to check on the status of the disease. If your doctor feels it is necessary, you may also have a magnetic resonance imaging (MRI). Women who are able to have children must have a negative blood or urine pregnancy test.
During treatment, you will receive irinotecan by vein over one hour, once a day for 5 days in a row. This will be followed by 2 days of no study drug treatment, then 5 more days of treatment with irinotecan. This 12-day period will be followed by 9 days of rest (no study drug). This 21-day period is called a cycle of therapy. You will continue to receive treatment (cycles repeated) as long as the disease does not get worse or until maximal shrinkage of the cancer. Treatment may be taken on an outpatient basis.
During treatment, you will have blood collected (1-2 teaspoons) once a week for routine tests. At least once every cycle of treatment (3 weeks) you will have a physical exam and be asked questions about you health.
After the first 2 cycles, the disease will be re-evaluated. You will have blood tests (1-2 teaspoons), x-rays, and CT scans. If your doctor feels it is necessary, you may also have a MRI. This re-evaluation will be repeated every 4 cycles.
If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Your doctor may choose to follow up with long-term exams at his/her discretion.
This is an investigational study. Irinotecan is FDA approved and is commercially available. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of all ages.
- Patients must have histologic proof of a sarcoma.
- Patients must have locally advanced / metastatic disease that is inoperable or incurable with surgery.
- If patient has a history of prior malignancy, there must be histologic documentation that metastatic disease is sarcoma.
- Patients must have received or refused standard chemotherapy for disease.
- Patients must have at least one lesion that is clearly defined, measurable or objectively evaluable. This lesion cannot have been previously irradiated unless progression has been demonstrated after radiation.
- Patients must have a life expectancy of at least 12 weeks and a Zubrod performance status of < 2.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital. The only approved consent form is appended to this protocol.
- Patients must receive no other concurrent chemotherapy or immunotherapies. Patients must have recovered from any previous chemotherapy. They must have been off treatment at least 4 weeks from the previous chemotherapy (6 weeks for stem cell toxins) and have recovered from any side effects or toxicity prior to the institution of irinotecan.
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte counts of at least 1000/cubic mm and platelet count of at least 50,000/cubic mm determined within 2 weeks prior to the first treatment.
- Patients should have adequate hepatic function with a bilirubin < 2 times the upper limit of normal, and Serum glutamic pyruvic transaminase (SGPT) < 3 times the upper limit of normal determined within 2 weeks prior to the first treatment.
Exclusion Criteria:
- Pregnant or lactating women will be excluded, due to unknown side effects on the fetus.
- Patients with severe pulmonary insufficiency will be excluded.
- Patients of childbearing potential not willing to utilize birth control during and for at least 3 months following completion of the trial shall not be eligible.
- Patients with an overt psychosis or mental disability, those with psychological or social situation that would interfere with study follow-up, or otherwise incompetent to give informed consent shall be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Irinotecan
Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days
|
16 mg/m2 by vein Daily Over 1 Hour x 5 Days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma
Time Frame: Four 3-week cycles (12 weeks)
|
Efficacy based on dose limiting toxicity (DLT).
Unacceptable toxicity is defined as grade 3 or 4 nonhematologic toxicity, or if expressed by the patient as unacceptable despite the grade.
Patients evaluated for toxicity at the end of each cycle.
|
Four 3-week cycles (12 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert S. Benjamin, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM03-0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
National Cancer Institute (NCI)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Adult Synovial SarcomaUnited States
Clinical Trials on Irinotecan
-
Shanghai Zhangjiang Biotechnology Limited CompanyShanghai Biomabs Pharmaceutical Co., Ltd.CompletedMetastatic Colorectal Cancer
-
ShengFa SuUnknownSmall-cell Lung CancerChina
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedGlioma | Astrocytoma | OligodendrogliomaUnited States
-
Nelson YeeIpsenActive, not recruitingLocally Advanced Pancreatic Carcinoma(LAPC)United States
-
Centre Oscar LambretSFCECompleted
-
Boston Scientific CorporationBiocompatibles UK LtdCompletedMetastatic Colorectal CancerUnited Kingdom, Austria, France
-
Baohui HanNot yet recruitingExtensive-stage Small-cell Lung CancerChina
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
Japan Clinical Cancer Research OrganizationTaiho Pharmaceutical Co., Ltd.Completed
-
Fudan UniversityNot yet recruitingSmall Cell Lung Cancer RecurrentChina