Non-Small-Cell Lung CarcinomaPhase 1NCT00102505
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Motexafin Gadolinium Injection in people with Non-Small-Cell Lung Carcinoma and Carcinoma, Bronchogenic, run by Pharmacyclics LLC. at 1 site in United States.
Trial summary
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer. A cycle consists of 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Carcinoma, Bronchogenic
- What is being tested?
- Motexafin Gadolinium Injection
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to not given
- 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
- ≥ 18 years old
- ECOG score of 0, 1, or 2
- Histologically confirmed diagnosis of non-small cell lung cancer
Who cannot join
- Laboratory values demonstrating inadequate function of the following:
- Bone marrow
- Kidneys
- Liver
- and
- Peripheral neuropathy Grade 2 or higher
- Greater than 2 prior chemotherapy regimens
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.
- Being tested
- Motexafin Gadolinium Injection
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Metastatic lung cancer, Inoperable lung cancer, Advanced lung cancer, Large-cell lung cancer, Adenocarcinoma, lung, Squamous cell carcinoma, lung, Squamous cell lung cancer, Large cell carcinoma, lung, Bronchogenic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Squamous Cell, Carcinoma, Large Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin Gadolinium InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Secondary outcomes (1)
Tumor response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2005 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102505
- Sponsor's protocol ID
- PCYC-0220
- Status last verified
- Apr 2009
- First submitted
- 29 Jan 2005
- Last updated
- 3 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00102505
- Acronym / sponsor ID
- PCYC-0220
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, Metastatic lung cancer, Inoperable lung cancer, Advanced lung cancer, Large-cell lung cancer, Adenocarcinoma, lung, Squamous cell carcinoma, lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- First posted
- 31 Jan 2005 (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.
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (3 listed)
- ≥ 18 years old
- ECOG score of 0, 1, or 2
- Histologically confirmed diagnosis of non-small cell lung cancer
Key exclusion criteria (7 listed)
- Bone marrow
- Kidneys
- Liver
- and
- Peripheral neuropathy Grade 2 or higher
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 |
|---|---|---|
| Motexafin Gadolinium Injection | Drug | – |
Primary outcome
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
1 secondary outcome
Tumor response
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 3 Apr 2009.
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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.
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 Motexafin Gadolinium Injection in people with Non-Small-Cell Lung Carcinoma and Carcinoma, Bronchogenic, run by Pharmacyclics LLC. 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 3 inclusion and 7 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 3 Apr 2009. 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?
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin. The study lists 2 primary outcomes in all. 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 3 Apr 2009.