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Irinotecan (Camptosar) in Patients With Advanced Sarcomas

Primary Purpose

Sarcoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Irinotecan

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Advanced Sarcomas, Irinotecan, Camptosar, CPT-11

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irinotecan

Arm Description

Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00509860

First Posted

July 30, 2007

Last Updated

December 28, 2012

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00509860

Brief Title

Irinotecan (Camptosar) in Patients With Advanced Sarcomas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

Advanced Sarcomas, Irinotecan, Camptosar, CPT-11

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Irinotecan

Arm Type

Experimental

Arm Description

Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

Camptosar, CPT-11

Intervention Description

16 mg/m2 by vein Daily Over 1 Hour x 5 Days

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Four 3-week cycles (12 weeks)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert S. Benjamin, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

The University of Texas M.D.Anderson Cancer Center

Learn more about this trial

Irinotecan (Camptosar) in Patients With Advanced Sarcomas

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