SarcomaPhase 2NCT00509860
Irinotecan (Camptosar) in Patients With Advanced Sarcomas
A Phase 2 study testing Irinotecan in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma. 2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2012
- 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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- Irinotecan
- Keywords
- Advanced Sarcomas, Irinotecan, Camptosar, CPT-11
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Camptosar, CPT-11
16 mg/m2 by vein Daily Over 1 Hour x 5 Days
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan | Experimental | Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma
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.
Measured: Four 3-week cycles (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startMar 2003
- Primary completionAug 2007
- Study completionJan 2012
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 M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert S. Benjamin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509860
- Sponsor's protocol ID
- DM03-0002
- Status last verified
- Dec 2012
- First submitted
- 30 Jul 2007
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas
- ClinicalTrials.gov ID
- NCT00509860
- Acronym / sponsor ID
- DM03-0002
- Conditions
- Sarcoma
- Keywords
- Advanced Sarcomas, Irinotecan, Camptosar, CPT-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Aug 2007 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan | Experimental | Drug: IrinotecanIrinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| IrinotecanAlso: Camptosar, CPT-1116 mg/m2 by vein Daily Over 1 Hour x 5 Days | Drug | Irinotecan |
Primary outcome
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.
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 3 Jan 2013.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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 S. Benjamin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan in people with Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
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 3 Jan 2013.