Irinotecan (Camptosar) in Patients With Advanced Sarcomas

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Camptothecin; Irinotecan

Criteria

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 irinotecan.

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 fetus.

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.