Back to resultsConcurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria: Patients with histologically proven non-small cell lung cancer Stage I to IIIA. Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon. PS < 2 Age > 18 years Life expectancy of > 12 weeks Normal hematologic, liver, and renal function No metastatic disease as determined by CT-PET scanning and bone scan. No brain metastasis by MRI No contraindication to radiotherapy Exclusion Criteria: Patients with uncontrolled CNS metastases. Active systemic infection. Serious, uncontrolled intercurrent medical or psychiatric illness. Secondary active primary malignancy. Inability to comply with requirements of the study. Any metastases outside of the mediastinum Histologically positive pleural or pericardial effusion Any chemotherapy within five years prior to enrollment on this protocol Prior radiotherapy administered to the chest Women who are pregnant or lactating FEV1 < 1 liter/minute
Sites / Locations
- University of New Mexico
Outcomes
Primary Outcome Measures
The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322751
Brief Title
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
Official Title
Phase I Study of Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer (NSCLC) (Stage I to IIIA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.
Detailed Description
This is a study of chemoradiation for patient with inoperable non small cell lung cancer with poor pulmonary function. These patients have usually very limited treatment options because of the compromised lung function. Chemoradiation is usually superior to radiation alone, but has not been extensively tested in this patient population. Topotecan is a drug approved for lung cancer that has synergistic activity with radiation. The study will determine what is the safest dose of topotecan to use with radiation in this patient population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.
Primary Outcome Measure Information:
Title
The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
Time Frame
Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically proven non-small cell lung cancer Stage I to IIIA.
Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon.
PS < 2
Age > 18 years
Life expectancy of > 12 weeks
Normal hematologic, liver, and renal function
No metastatic disease as determined by CT-PET scanning and bone scan.
No brain metastasis by MRI
No contraindication to radiotherapy
Exclusion Criteria:
Patients with uncontrolled CNS metastases.
Active systemic infection.
Serious, uncontrolled intercurrent medical or psychiatric illness.
Secondary active primary malignancy.
Inability to comply with requirements of the study.
Any metastases outside of the mediastinum
Histologically positive pleural or pericardial effusion
Any chemotherapy within five years prior to enrollment on this protocol
Prior radiotherapy administered to the chest
Women who are pregnant or lactating
FEV1 < 1 liter/minute
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennie Jones, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
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