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A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas

Phase 2
Not Enrolling

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Trial Information

A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas

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.

Inclusion Criteria:

1. Patients of all ages.

2. Patients must have histologic proof of a sarcoma.

3. Patients must have locally advanced / metastatic disease that is inoperable or
incurable with surgery.

4. If patient has a history of prior malignancy, there must be histologic documentation
that metastatic disease is sarcoma.

5. Patients must have received or refused standard chemotherapy for disease.

6. 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.

7. Patients must have a life expectancy of at least 12 weeks and a Zubrod performance
status of < 2.

8. 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.

9. 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

10. 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.

11. 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:

1. Pregnant or lactating women will be excluded, due to unknown side effects on the

2. Patients with severe pulmonary insufficiency will be excluded.

3. 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.

4. 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma

Outcome Description:

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.

Outcome Time Frame:

Four 3-week cycles (12 weeks)

Safety Issue:


Principal Investigator

Robert S. Benjamin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2003

Completion Date:

January 2012

Related Keywords:

  • Sarcoma
  • Advanced Sarcomas
  • Irinotecan
  • Camptosar
  • CPT-11
  • Sarcoma



UT MD Anderson Cancer Center Houston, Texas  77030