Lung CancerPhase 1NCT00322751
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
A Phase 1 study testing Topotecan in people with Lung Cancer, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Topotecan
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- No metastatic disease as determined by CT-PET scanning and bone scan.
- No brain metastasis by MRI
- No contraindication to radiotherapy
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
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)
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- Topotecan
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
Measured: Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Dennie Jones, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322751
- Sponsor's protocol ID
- INST 0529C
- Status last verified
- Nov 2009
- First submitted
- 5 May 2006
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00322751
- Acronym / sponsor ID
- INST 0529C
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopotecanThe 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. | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennie Jones, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan in people with Lung Cancer, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2010.