Lung CancerPhase 2NCT00373204
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)
A Phase 2 study testing Motexafin Gadolinium in people with Lung Cancer, run by Pharmacyclics LLC. at 22 sites in 4 countries.
Trial summary
The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer. 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?
- Motexafin Gadolinium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 22 sitesin 4 countries
- Study dates
- May 2006to May 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 old
- Histologically or cytologically confirmed diagnosis of NSCLC
- Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen
- Measurable disease per RECIST
- ECOG performance status score of 0 or 1
- Willing and able to provide written informed consent
Who cannot join
- Laboratory values of: ANC < 1500/mm³, Platelet count < 100,000/mm³, hemoglobin < 10 g/dL, AST or ALT > 2.5 x upper limit of normal (ULN), Alkaline phosphatase > 5 x ULN, bilirubin > 1.5 x ULN, serum creatinine > 2.0 mg/dL (176 umol/dL), albumin < 3.0 g/dL (30 g/L)
- Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases
- Evidence of meningeal metastasis
- > 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen, or prior MGd)
- Chemotherapy, radiation therapy, experimental therapy, immunotherapy, or systemic biologic anticancer therapy within 21 days before beginning study treatment
- Significant weight loss ≥ 10% of body weight within preceding 6 weeks
Show all 16Show fewer
- Treatment for another cancer within 3 years before enrollment, except basal cell carcinoma of the skin or cervical cancer in situ
- Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association Class III or IV
- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy)
- Known history of porphyria (testing not required at screening visit)
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit)
- History of hypersensitivity to taxanes or polysorbate 80
- Known history of HIV infection (testing not required at screening visit)
- Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential)
- Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection
- Physical or mental condition that makes patient unable to complete specified follow-up assessments
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Russia8 sites
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk
Blokhin Cancer Research Center (Dept. of Chemotherapy)
Moscow
Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)
Moscow
Central Clinical Hospital
Moscow
Moscow Oncology Hospital #62
Moscow
St. Petersburg City Oncology Center
Saint Petersburg
Samara Regional Oncology Center
Samara
Regional Oncology Dispensary
Yaroslavl
United States7 sites
Tri-County Hematology & Oncology Associates
Canton, Ohio
Cancer Specialists of Tidewater
Chesapeake, Virginia
University of Cincinnati
Cincinnati, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio
Wilshire Oncology Medical Group
La Verne, California
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania
University of Rochester
Rochester, New York
Serbia4 sites
Clinic for Pulmonary Diseases, Military Medical Academy
Belgrade
Clinic for Pulmonary Diseases
Belgrade
Institute for Oncology and Radiology of Serbia
Belgrade
Institute for Pulmonary Diseases of Vojvodina
Kamenitz
Canada3 sites
Hospital Charles Lemoyne
Greenfield Park, Quebec
Cancer Centre of Southeastern Ontario
Kingston, Ontario
Jewish General Hospital
Montreal, Quebec
About this study
Official title: Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.
Read the detailed description
Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.
- Conditions
- Lung Cancer
- Being tested
- Motexafin Gadolinium
- Keywords
- Advanced non-small cell lung cancer, Non-small cell lung cancer, Lung cancer, Metastatic lung cancer, Second line treatment for advanced lung cancer, Cancer, Advanced lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin GadoliniumDrug
Also called MGd and Docetaxtel
On Day 1 of each 3 week cycle for up to 12 cycles:
MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Xcytrin® (motexafin gadolinium) | Experimental | Not described Receives: Drug: Motexafin Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
Measured: up to 12 cycles
Secondary outcomes (6)
To estimate the time of progression
The progression is defined as the time fromfirst does of MGd to first eviedence of progression
Measured: up to 12 cycles
To estimate overall survival
The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel
Measured: up to 12 cycles
To estimate progression-free survival
Progression-free survival is defined as the time from first does of MGd to the earlier of progression
Measured: up to 12 cycles
To estimate duration of response (CR + PR)
Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.
Measured: Up to 12 cycles
To estimate clinical benefit rate (CR + PR + stable disease [SD])
The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation
Measured: up to 12 cycles
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC
All patients who receive at one dose of MGd will be included in the safety summaries and analyses
Measured: Up to 12 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2008
- Study completionMay 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kishan Pandya, MD, Study chair, University of Rochester, Rochester, NY, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373204
- Sponsor's protocol ID
- PCYC-0229
- Status last verified
- Jul 2014
- First submitted
- 5 Sep 2006
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00373204
- Acronym / sponsor ID
- PCYC-0229
- Conditions
- Lung Cancer
- Keywords
- Advanced non-small cell lung cancer, Non-small cell lung cancer, Lung cancer, Metastatic lung cancer, Second line treatment for advanced lung cancer, Cancer, Advanced lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Sep 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 purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.
Detailed description
Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years old
- Histologically or cytologically confirmed diagnosis of NSCLC
- Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen
- Measurable disease per RECIST
- ECOG performance status score of 0 or 1
Key exclusion criteria (16 listed)
- Laboratory values of: ANC < 1500/mm³, Platelet count < 100,000/mm³, hemoglobin < 10 g/dL, AST or ALT > 2.5 x upper limit of normal (ULN), Alkaline phosphatase > 5 x ULN, bilirubin > 1.5 x ULN, serum creatinine > 2.0 mg/dL (176 umol/dL), albumin < 3.0 g/dL (30 g/L)
- Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases
- Evidence of meningeal metastasis
- > 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen, or prior MGd)
- Chemotherapy, radiation therapy, experimental therapy, immunotherapy, or systemic biologic anticancer therapy within 21 days before beginning study treatment
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 GadoliniumAlso: MGd and DocetaxtelOn Day 1 of each 3 week cycle for up to 12 cycles: MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour. | Drug | Xcytrin® (motexafin gadolinium) |
Primary outcome
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel
Time frame: up to 12 cycles
The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.
6 secondary outcomes
To estimate the time of progression
Time frame: up to 12 cycles
To estimate overall survival
Time frame: up to 12 cycles
To estimate progression-free survival
Time frame: up to 12 cycles
To estimate duration of response (CR + PR)
Time frame: Up to 12 cycles
To estimate clinical benefit rate (CR + PR + stable disease [SD])
Time frame: up to 12 cycles
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC
Time frame: Up to 12 cycles
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 24 Jul 2014.
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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.
Kishan Pandya, MD study chair
University of Rochester, Rochester, NY, USA
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motexafin Gadolinium in people with Lung Cancer, run by Pharmacyclics LLC. at 22 sites in 4 countries.
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 6 inclusion and 16 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia, United States, Serbia, Canada. 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?
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel (time frame: up to 12 cycles). 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 24 Jul 2014.