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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
NSCLC

Thank you

Trial Information

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


Inclusion Criteria:



1. Women with baseline estradiol >25 pg/mL

2. Histologically- or cytologically-confirmed diagnosis of NSCLC.

3. ECOG performance score (PS) of 0, 1, or 2.

4. 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.

5. At least 18 years of age.

6. Adequate bone marrow function

7. Adequate renal function

8. Adequate hepatic function

9. Life expectancy ≥12 weeks

Exclusion Criteria:

1. Known hypersensitivity to the excipients or the study drug (either CT-2103,
paclitaxel, or carboplatin that the patient will receive.

2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology.

3. Weight loss >10% in previous 6 months

4. LDH > 2.5X IULN

5. Both LDH > 1.5X IULN and ≥ 5% weight loss in previous 6 months

6. BMI >35

7. Any prior systemic chemotherapy for the treatment of lung cancer. This includes
systemic radiosensitizers used to treat brain metastases and any biologic agent.

8. Local palliative radiotherapy < 7 days before randomization.

9. Radiation with curative intent < 30 days before randomization.

10. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin
cancer.

11. Grade 2 or greater neuropathy.

12. Evidence of significant unstable neurological symptoms within the 4 weeks before
study randomization.

13. Clinically significant active infection for which active therapy is underway.

14. Investigational therapy within 4 weeks before randomization, unless local
requirements are more stringent.

15. Unstable medical conditions including unstable angina or myocardial infarction within
the past 6 months before randomization.

16. Pregnant women or nursing mothers.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

up to 3 years post treatment

Safety Issue:

No

Principal Investigator

Jack W. Singer, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

PGT307

NCT ID:

NCT00576225

Start Date:

September 2007

Completion Date:

January 2014

Related Keywords:

  • NSCLC
  • NSCLC
  • women
  • CT-2103
  • paclitaxel
  • carboplatin
  • Carcinoma, Non-Small-Cell Lung

Name

Location

New York Medical CollegeValhalla, New York  10595
Virginia Mason Medical CenterSeattle, Washington  98111
Hartford HospitalHartford, Connecticut  06102-5037
Southwest Regional Cancer CenterAustin, Texas  78705
Stanford Cancer CenterStanford, California  94305-5824
Cancer Care CenterNew Albany, Indiana  47150
Arena Oncology AssociatesGreat Neck, New York  11021
Lincoln Medical and Mental Health CenterBronx, New York  10451
Southwest Cancer CarePoway, California  92064
Mary Crowley Medical Research CenterDallas, Texas  75246
Northern Utah AssociatesOgden, Utah  84403
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Mayo ClinicScottsdale, Arizona  
Providence St. Joseph Medical CenterBurbank, California  91505
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
St. Louis UniversitySt. Louis, Missouri  63110
Las Vegas Cancer CenterLas Vegas, Nevada  89102
Loyola UniversityMaywood, Illinois  60153
The Family Cancer CenterCollierville, Tennessee  38017
VA Sierra Nevada Health Care SystemReno, Nevada  89502
Kansas City Cancer CenterKansas City, Kansas  66112
Vita Hematology Oncology, P.C.Bethlehem, Pennsylvania  18015
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Hematology Oncology ConsultantsNaperville, Illinois  60540
Joliet Oncology Hematology Associates, LtdJoliet, Illinois  60435
Providence Medical GroupTerre Haute, Indiana  47802
Lone Star Oncology ConsultantsAustin, Texas  78759
Richmond University Medical CenterStaten Island, New York  10310-1699
Memorial Cancer InstitutePembroke Pines, Florida  33028
Columbia Comprehensive Cancer Care ClinicsColumbia, Missouri  65201
Mid-South Cancer CenterGermantown, Tennessee  38138
Horizon Institute for Clinical ResearchHollywood, Florida  33021
Scottsdale Medical SpecialistsScottsdale, Arizona  85258
Hattiesburg ClinicHattiesburg, Mississippi  39401
Hembree Regional Cancer CenterFort Smith, Arkansas  72903
Clinical Trials & Research InstituteMontebello, California  90640
Family Medicine of Vincennes Clinical Trials CenterVincennes, Indiana  47591
Henry Ford Health System, Josephine Ford Cancer CenterDetroit, Michigan  48202
W. Michigan Regional Cancer & Blood CenterFreesoil, Michigan  49411
St Alexius Medical CenterBismark, North Dakota  58501
Blood and Cancer CenterCanfield, Ohio  44406
Aultman Hospital Clinical TrialsCanton, Ohio  44710
UIMA, Inc / University of Cincinnati-Barrett Cancer CenterCincinnati, Ohio  45267
Cancer Outreach Associates, LLCArlington, Virginia  24211