NCT00509860

Brief Summary

Primary Objectives:

  1. 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. 2.To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

4.4 years

First QC Date

July 30, 2007

Last Update Submit

December 28, 2012

Conditions

Sarcoma

Keywords

Advanced SarcomasIrinotecanCamptosarCPT-11

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four 3-week cycles (12 weeks)

Study Arms (1)

Irinotecan

EXPERIMENTAL

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

Drug: Irinotecan

Interventions

IrinotecanDRUG

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

Also known as: Camptosar, CPT-11
Irinotecan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Robert S. Benjamin, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

March 1, 2003

Primary Completion

August 1, 2007

Study Completion

January 1, 2012

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

US(1)