Non-Small Cell Lung CarcinomaPhase 2NCT00365183
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing Motexafin gadolinium and pemetrexed in people with Non-Small Cell Lung Carcinoma, run by Pharmacyclics LLC. at 11 sites in United States.
Trial summary
The goals of this study are: to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Carcinoma
- What is being tested?
- Motexafin gadolinium and pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2006to Jun 2008
- Phase
- Phase 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
- 18 years or older
- Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
- ECOG performance status score of 0 or 1
Who cannot join
- Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
- Symptomatic or uncontrolled brain metastases
- Evidence of meningeal metastasis
- > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
- Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Albuquerque, New Mexico
Study site
Armonk, New York
Study site
Baltimore, Maryland
Study site
Chicago, Illinois
Study site
Columbus, Ohio
Study site
Huntington Beach, California
Study site
Long Beach, California
Study site
Minneapolis, Minnesota
Study site
Santa Fe, New Mexico
Study site
Seattle, Washington
Study site
St Louis, Missouri
About this study
Official title: Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
The goals of this study are:
- to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
- to assess response to treatment in patients with NSCLC six months after beginning study treatment.
- Conditions
- Non-Small Cell Lung Carcinoma
- Being tested
- Motexafin gadolinium and pemetrexed
- 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, Cancer of the Lung, Carcinoma, Bronchogenic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Squamous Cell, Carcinoma, Large Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin gadolinium and pemetrexedDrug
Also called MGd and Alimta®
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| Xcytrin® (motexafin gadolinium) | Experimental | Not described Receives: Drug: Motexafin gadolinium and pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month progression free survival
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
Measured: up to 2 years
Secondary outcomes (7)
Time to disease progression
Time to progression is defined as the time from first dose of MGd to first evidence of progression.
Measured: up to 2 years
Overall survival
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
Measured: up to 2 years
Progression free survival
Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
Measured: up to 2 years
Response rate (CR+PR) by RECIST criteria
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
Measured: up to 2 years
Duaration of reponse (CR+PR)
Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
Measured: up to 2 years
Clinical benefit rate (CR+PR+SD)
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
Measured: up to 2 years
Safety and tolerability of MGd and pemetrexed
All patients who receive any MGd will be included in the safety summaries and analyses
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Edelman, MD, Study chair, University of Maryland, Greenbaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365183
- Sponsor's protocol ID
- PCYC-0228
- Status last verified
- Oct 2013
- First submitted
- 15 Aug 2006
- Last updated
- 31 Oct 2013
- Results posted
- No
Publications
Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8.
PubMed 15684606Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98.
PubMed 15627019
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00365183
- Acronym / sponsor ID
- PCYC-0228
- Conditions
- Non-Small Cell Lung Carcinoma
- 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 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Aug 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.
The goals of this study are:
- to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
- to assess response to treatment in patients with NSCLC six months after beginning study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xcytrin® (motexafin gadolinium) | Experimental | Drug: Motexafin gadolinium and pemetrexed |
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 or older
- Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
- ECOG performance status score of 0 or 1
Key exclusion criteria (5 listed)
- Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
- Symptomatic or uncontrolled brain metastases
- Evidence of meningeal metastasis
- > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
- Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
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 and pemetrexedAlso: MGd and Alimta®1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles | Drug | Xcytrin® (motexafin gadolinium) |
Primary outcome
6 month progression free survival
Time frame: up to 2 years
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
7 secondary outcomes
Time to disease progression
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Progression free survival
Time frame: up to 2 years
Response rate (CR+PR) by RECIST criteria
Time frame: up to 2 years
Duaration of reponse (CR+PR)
Time frame: up to 2 years
Clinical benefit rate (CR+PR+SD)
Time frame: up to 2 years
Safety and tolerability of MGd and pemetrexed
Time frame: up to 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 15684606Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8.
- Background: PubMed 15627019Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98.
Related trials for Non-Small Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Martin Edelman, MD study chair
University of Maryland, Greenbaum Cancer Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motexafin gadolinium and pemetrexed in people with Non-Small Cell Lung Carcinoma, run by Pharmacyclics LLC. at 11 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 phase mean?
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?
The study was stopped early. 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.
What does the primary outcome measure?
6 month progression free survival (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365183, which also lists 2 linked publications.
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 31 Oct 2013.