NSCLCPhase 3NCT00576225
CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
A Phase 3 study testing CT-2103/carboplatin and paclitaxel/carboplatin in people with NSCLC, run by CTI BioPharma at 44 sites in United States.
Trial summary
This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- NSCLC
- What is being tested?
- CT-2103/carboplatin and paclitaxel/carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 44 sitesUnited States
- Study dates
- Sep 2007to 5 Apr 2010
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with baseline estradiol >25 pg/mL
- Histologically- or cytologically-confirmed diagnosis of NSCLC.
- ECOG performance score (PS) of 0, 1, or 2.
- Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
- At least 18 years of age.
- Adequate bone marrow function
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- Adequate renal function
- Adequate hepatic function
- Life expectancy ≥12 weeks
Who cannot join
- Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
- Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
- Weight loss >10% in previous 6 months
- LDH > 2.5X IULN
- Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months
- BMI >35
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- Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
- Local palliative radiotherapy < 7 days before randomization.
- Radiation with curative intent < 30 days before randomization.
- Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
- Grade 2 or greater neuropathy.
- Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization.
- Clinically significant active infection for which active therapy is underway.
- Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
- Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization.
- Pregnant women or nursing mothers.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Cancer Outreach Associates, LLC
Arlington, Virginia, 24211
Southwest Regional Cancer Center
Austin, Texas, 78705
Lone Star Oncology Consultants
Austin, Texas, 78759
St Alexius Medical Center
Bismarck, North Dakota, 58501
Providence St. Joseph Medical Center
Burbank, California, 91505
Blood and Cancer Center
Canfield, Ohio, 44406
Aultman Hospital Clinical Trials
Canton, Ohio, 44710
UIMA, Inc / University of Cincinnati-Barrett Cancer Center
Cincinnati, Ohio, 45267
The Family Cancer Center
Collierville, Tennessee, 38017
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Henry Ford Health System, Josephine Ford Cancer Center
Detroit, Michigan, 48202
Southwest Cancer Care
Escondido, California, 92025
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
Hembree Regional Cancer Center
Fort Smith, Arkansas, 72903
Vita Hematology Oncology, P.C.
Fountain Hill, Pennsylvania, 18105
W. Michigan Regional Cancer & Blood Center
Free Soil, Michigan, 49411
Mid-South Cancer Center
Germantown, Tennessee, 38138
Hartford Hospital
Hartford, Connecticut, 06102
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Las Vegas Cancer Center
Henderson, Nevada, 89052
Horizon Institute for Clinical Research
Hollywood, Florida, 33021
Memorial Cancer Institute
Hollywood, Florida, 33021
Columbia Comprehensive Cancer Care Clinics
Jefferson City, Missouri, 65109
Joliet Oncology Hematology Associates, Ltd
Joliet, Illinois, 60435
Loyola University
Maywood, Illinois, 60153
Clinical Trials & Research Institute
Montebello, California, 90640
Hematology Oncology Consultants
Naperville, Illinois, 60540
Cancer Care Center
New Albany, Indiana, 47150
Lincoln Medical and Mental Health Center
New York, New York, 10451
Arena Oncology Associates
New York, New York, 11042
Northern Utah Associates
Ogden, Utah, 84403
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73117
Kansas City Cancer Center
Overland Park, Kansas, 66210
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
Scottsdale Medical Specialists
Scottsdale, Arizona, 85258
Mayo Clinic
Scottsdale, Arizona, 85259
Virginia Mason Medical Center
Seattle, Washington, 98111
St. Louis University
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
Richmond University Medical Center
Staten Island, New York, 10310
Pasco Pinellas Cancer Center
Tarpon Springs, Florida, 34691
Providence Medical Group
Terre Haute, Indiana, 47802
New York Medical College
Valhalla, New York, 10595
Family Medicine of Vincennes Clinical Trials Center
Vincennes, Indiana, 47591
About this study
Official title: Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL
This study is designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.
- Conditions
- NSCLC
- Being tested
- CT-2103/carboplatin, paclitaxel/carboplatin
- Keywords
- NSCLC, women, CT-2103, paclitaxel, carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-2103/carboplatinDrug
CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
paclitaxel/carboplatinDrug
Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: CT-2103/carboplatin |
| Control | Active comparator | Not described Receives: Drug: paclitaxel/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: up to 3 years post treatment
Secondary outcomes (1)
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
Measured: up to 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2007
- Primary completion5 Apr 2010
- Study completion5 Apr 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack W. Singer, M.D., Study director, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576225
- Sponsor's protocol ID
- PGT307
- Status last verified
- Oct 2020
- First submitted
- 17 Dec 2007
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL
- ClinicalTrials.gov ID
- NCT00576225
- Acronym / sponsor ID
- PGT307
- Conditions
- NSCLC
- Keywords
- NSCLC, women, CT-2103, paclitaxel, carboplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- 5 Apr 2010 (actual)
- Study completion
- 5 Apr 2010 (actual)
- First posted
- 19 Dec 2007 (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 designed to test whether CT-2103/carboplatin provides improved overall survival compared to paclitaxel/carboplatin in women with NSCLC who have estradiol levels >30 pg/ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: CT-2103/carboplatin |
| Control | Active comparator | Drug: paclitaxel/carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women with baseline estradiol >25 pg/mL
- Histologically- or cytologically-confirmed diagnosis of NSCLC.
- ECOG performance score (PS) of 0, 1, or 2.
- Patients must meet one of the following criteria have either (1) Recurrent disease following completion of radiation or surgery, (2) Stage IIIB disease and not be a candidate for combined modality therapy (primary radiation therapy or surgery), or (3) Stage IV disease.
- At least 18 years of age.
Key exclusion criteria (16 listed)
- Known hypersensitivity to the excipients or the study drug (either CT-2103, paclitaxel, or carboplatin that the patient will receive.
- Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
- Weight loss >10% in previous 6 months
- LDH > 2.5X IULN
- Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months
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 |
|---|---|---|
| CT-2103/carboplatinCT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles. | Drug | Experimental |
| paclitaxel/carboplatinPaclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles. | Drug | Control |
Primary outcome
Survival
Time frame: up to 3 years post treatment
1 secondary outcome
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
Time frame: up to 3 years post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Jack W. Singer, M.D. study director
CTI BioPharma
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-2103/carboplatin and paclitaxel/carboplatin in people with NSCLC, run by CTI BioPharma at 44 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 9 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Survival (time frame: up to 3 years post treatment). 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 19 Oct 2020.