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Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2.


Phase 3
18 Years
N/A
Not Enrolling
Female
NSCLC

Thank you

Trial Information

Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2.


See Summary


Inclusion Criteria:



1. Female.

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

3. ECOG performance score of 2.

4. Patients who meet one of the following criteria:

- Stage IIIB who are not candidates for combined modality therapy (primary
radiation therapy or surgery), or

- Stage IV.

5. Age greater than or equal to 18 years.

6. Adequate bone marrow function

7. Adequate renal function

8. Adequate hepatic function

9. Patients with known brain metastases must have received standard antitumor treatment
for their CNS metastases as defined by the site’s institutional standards.

10. Patients who have had major surgery must be fully recovered from the surgery.

11. Ability to comply with the visit schedule and assessments required by the protocol.

12. For patients of reproductive potential, commitment to use adequate contraception.

13. Signed approved informed consent, with understanding of study procedures.

14. Agreement to begin study therapy within 8 calendar days after randomization.

Exclusion Criteria:

1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate,
monobasic sodium phosphate (the excipients of CT-2103).

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

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

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

5. Grade 2 or greater neuropathy.

6. Evidence of significant unstable neurological symptoms within the 4 weeks before
study randomization. (If unstable neurologic symptoms resulted from brain metastases,
patient must meet inclusion criteria number 9).

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

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

9. Unstable medical conditions including unstable angina or myocardial infarction within
the past 6 months before randomization. Patients with evidence of cardiac conduction
abnormalities are eligible if their cardiac status is stable.

10. Pregnant women or nursing mothers.

11. Any circumstance at the time of study entry that would preclude completion of the
study or the required follow-up.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.

Authority:

United States: Food and Drug Administration

Study ID:

PGT305

NCT ID:

NCT00269828

Start Date:

December 2005

Completion Date:

December 2006

Related Keywords:

  • NSCLC
  • Non-small cell lung cancer
  • NSCLC
  • PS 2
  • female
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
SUNY Downstate Medical CenterBrooklyn, New York  11203
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Our Lady of Mercy Medical CenterBronx, New York  10466
St. Alexius Medical CenterBismarck, North Dakota  58502
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Pacific Shores Medical GroupLong Beach, California  90813
Alamance Cancer CenterBurlington, North Carolina  27216
Loma Linda University Cancer InstituteLoma Linda, California  92354
Metro Health Medical CenterCleveland, Ohio  44109
Mary Crowley Medical Research CenterDallas, Texas  75246
Genesis Cancer CenterHot Springs, Arkansas  71913
Bond ClinicRolla, Missouri  65401
Saint Louis UniversitySt. Louis, Missouri  63104
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
Medical Oncology Care AssociatesOrange, California  92668
Tower Cancer Research FoundationBeverly Hills, California  90211
Flint, Michigan  48532
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Providence St. Joseph Medical CenterBurbank, California  91505
The Cleveland Clinic Foundation, Taussig Cancer CenterCleveland, Ohio  44195
Charleston Hematology OncologyCharleston, South Carolina  29403
Dayton Clinical Oncology ProgramDayton, Ohio  45420
Kentucky Cancer ClinicPikeville, Kentucky  41501
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Cabrini Center for Cancer CareAlexandria, Louisiana  71301
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Cancer & Blood Disease CenterLecanto, Florida  34461
The Family Cancer CenterCollierville, Tennessee  38017
Heritage Physician Group, OncologyHot Springs, Arkansas  71913
Northwestern Carolina Oncology & HematologyHickory, North Carolina  28601
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
Signal Point Hematology/Oncology, Inc.Middletown, Ohio  45042
JPS Center for Cancer CareFort Worth, Texas  76104
Sierra Nevada Oncology CareCarson City, Nevada  89703
Interlakes Foundation, Inc.Rochester, New York  14623
West Kentucky Hematology & Oncology Group, PSCPaducah, Kentucky  42003
Arizona Hematology OncologyTucson, Arizona  85704
Pacific Cancer Medical Center, IncAnaheim, California  92801
Hematology/Oncology Group of Fresno, IncFresno, California  93720
Comprehensive Cancer Center-Research OfficeGlendale, California  91204
The Cancer Research and Prevention CenterSoquel, California  95073
Bethesda Research CenterBoynton Beach, Florida  33435
Florida WellcareInverness, Florida  34452
Oncology-Hematology Associates of West BrowardTamarac, Florida  33321
Hematology Oncology SpeaclistTampa, Florida  33607
Joliet Oncology Hematology Associates, Ltd.Joliet, Illinois  60435
Loyola University Health SystemsMaywood, Illinois  60153
Mid-Illinois HEM & ONC Assoc.Normal, Illinois  61761
Associated Physicians & Surgeons ClinicTerre Haute, Indiana  47804
St. Louis Cancer Care CenterChesterfield, Missouri  63017
Columbia Comprehensive Cancer Care ClinicsColumbia, Missouri  65201
Washington University Siteman Cancer Center PharmacySt. Louis, Missouri  63110
Essex Oncology of North Jersey, PABelleville, New Jersey  07109
Atlanta HEM ONCManasquan, New Jersey  08736
Oncology and Hematology Specialist, PAMoutain Lakes, New Jersey  07046
San Juan Oncology AssociationFarmington, New Mexico  87401
Cancer Treatment ServicesCorning, New York  14830
Guthrie ClinicSayre, New York  18840
New York Medical CollegwValhalla, New York  10595
UNC Chapel Hill Oncology Protocol OfficeChapel Hill, North Carolina  27599
Leo Jenkins Cancer CenterGreenville, North Carolina  28734
University of ClevelandCleveland, Ohio  44106
Columbia Basin HEM/ONCKennewick, Washington  99336