NSCLCPhase 1/2NCT00082472
Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
A Phase 1/2 study testing Doxorubicin HCl Inhalation Solution, Docetaxel and Cisplatin in people with NSCLC, run by Zivena at 6 sites in United States.
Trial summary
This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Doxorubicin HCl Inhalation Solution, Docetaxel and Cisplatin
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2004to not given
- Phase
- Phase 1/2
- 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
- Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible.
- No prior chemotherapy or biologic therapy for lung cancer
- Measurable or evaluable pulmonary disease required
- Age > 18 years
- ECOG performance status of 0-1
- Adequate bone marrow, hepatic, and renal function
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- Total bilirubin < ULN
- SGOT and/or SGPT may be up to 2.5 x ULN if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4 x ULN if SGOT and SGPT are both ≤ ULN
- Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min/1.7 m2 BSA
- Patients must have the following pulmonary function test values:
- DLCO > 50% predicted. (DLCO must be adjusted for the patient's hemoglobin)
- FVC> 50% of predicted
- FEV1 >50% of predicted
- Resting oxygen saturation > 90%
- Exercise oxygen saturation > 85%
- Prior surgery is permitted provided full recovery has occurred
- Patients may not have received prior radiotherapy to the lungs. Patients with only chest wall or breast irradiation are eligible provided there is no radiographic evidence of pulmonary damage attributed to radiation therapy. Patients who have undergone Radioactive Iodine (RAI) therapy are also eligible.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Who cannot join
- Women must not be pregnant or breast-feeding during this study. Men and women with reproductive potential must use an effective contraceptive method while on this study and agree to use an effective method for three months after completing chemotherapy.
- Patients with large obstructive pulmonary lesions that may cause blockage of delivery of aerosolized drug to the affected lung, in the judgment of the treating physician. A ventilation scan is recommended if the status is unclear.
- Patients with other active malignancies. Patients with a history of prior malignancy other than NSCLC must not have received chemotherapy within the past 5 years and may not have had prior therapy with mitomycin (> 25 mg/m2), bleomycin or nitrosoureas (> 200 mg/m2). The patient may not have had any indication of pulmonary toxicity from the chemotherapy.
- Serious active infections which are not controlled such that the patient continues to manifest symptoms despite treatment
- Patients with progressive extra-pulmonary metastases who are unlikely to benefit from systemic or inhaled chemotherapy, e.g., extensive liver metastases, untreated brain metastases or treated brain metastases which are not clinically stable. If patients have received radiation treatment for brain metastases, at least 3 weeks must have elapsed since the last treatment and the patient must have recovered from all toxicity, not be receiving corticosteroids and have stable neurologic function off corticosteroids.
- Patients with known hypersensitivity to platinum compounds or taxanes or other drugs formulated with polysorbate 80
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- asthma
- uncontrolled diabetes mellitus
- Patients who have undergone lung transplantation
- unstable angina, congestive heart failure, or symptomatic arrhythmias or any other serious illness or medical condition that in the judgment of the investigator compromises the patient's safety
- clinically significant neuropathy (≥ Grade 1) by history or physical examination
- Patients using other investigational drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University
Columbus, Ohio, 43210
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Nevada Cancer Institute
Las Vegas, Nevada, 89135
University of Wisconsin Cancer Center
Madison, Wisconsin, 53792
Yale University Cancer Center
New Haven, Connecticut, 06520
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Phase I/II Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer
This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination.
Read the detailed description
Primary Objective of Phase I
- To determine the maximal and Phase II dose of inhaled doxorubicin HCl when given in combination with IV docetaxel and cisplatin in patients with locally advanced or metastatic unresectable NSCLC who have not been previously treated with chemotherapy.
Primary Objective of Phase II
- To obtain preliminary evidence of therapeutic activity using imaging studies in patients with measurable or evaluable lung lesions and serial measurements of disease-related pulmonary symptoms and pulmonary function.
Secondary Objective
- To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin.
- Conditions
- NSCLC
- Keywords
- NSCLC, Metastatic, Unresectable, No Prior Chemotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2004 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Zivena
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082472
- Sponsor's protocol ID
- Dox-2a-07
- Status last verified
- Apr 2006
- First submitted
- 11 May 2004
- Last updated
- 18 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00082472
- Acronym / sponsor ID
- Dox-2a-07
- Conditions
- NSCLC
- Keywords
- NSCLC, Metastatic, Unresectable, No Prior Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- ZivenaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- First posted
- 12 May 2004 (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.
This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime, to investigate the additional toxicities and to show initial evidence of efficacy of the combination.
Detailed description
Primary Objective of Phase I
- To determine the maximal and Phase II dose of inhaled doxorubicin HCl when given in combination with IV docetaxel and cisplatin in patients with locally advanced or metastatic unresectable NSCLC who have not been previously treated with chemotherapy.
Primary Objective of Phase II
- To obtain preliminary evidence of therapeutic activity using imaging studies in patients with measurable or evaluable lung lesions and serial measurements of disease-related pulmonary symptoms and pulmonary function.
Secondary Objective
- To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin.
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 (18 listed)
- Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible.
- No prior chemotherapy or biologic therapy for lung cancer
- Measurable or evaluable pulmonary disease required
- Age > 18 years
- ECOG performance status of 0-1
Key exclusion criteria (12 listed)
- Women must not be pregnant or breast-feeding during this study. Men and women with reproductive potential must use an effective contraceptive method while on this study and agree to use an effective method for three months after completing chemotherapy.
- Patients with large obstructive pulmonary lesions that may cause blockage of delivery of aerosolized drug to the affected lung, in the judgment of the treating physician. A ventilation scan is recommended if the status is unclear.
- Patients with other active malignancies. Patients with a history of prior malignancy other than NSCLC must not have received chemotherapy within the past 5 years and may not have had prior therapy with mitomycin (> 25 mg/m2), bleomycin or nitrosoureas (> 200 mg/m2). The patient may not have had any indication of pulmonary toxicity from the chemotherapy.
- Serious active infections which are not controlled such that the patient continues to manifest symptoms despite treatment
- Patients with progressive extra-pulmonary metastases who are unlikely to benefit from systemic or inhaled chemotherapy, e.g., extensive liver metastases, untreated brain metastases or treated brain metastases which are not clinically stable. If patients have received radiation treatment for brain metastases, at least 3 weeks must have elapsed since the last treatment and the patient must have recovered from all toxicity, not be receiving corticosteroids and have stable neurologic function off corticosteroids.
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 |
|---|---|---|
| Doxorubicin HCl Inhalation Solution | Drug | – |
| Docetaxel | Drug | – |
| Cisplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Doxorubicin HCl Inhalation Solution, Docetaxel and Cisplatin in people with NSCLC, run by Zivena at 6 sites 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 18 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 18 Apr 2006.