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CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL

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ClinicalTrials.gov Identifier: NCT00576225
Recruitment Status : Withdrawn
First Posted : December 19, 2007
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE December 19, 2007
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE September 2007
Actual Primary Completion Date April 5, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Survival [ Time Frame: up to 3 years post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety [ Time Frame: up to 3 years post treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE
  • Drug: CT-2103/carboplatin
    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.
  • Drug: paclitaxel/carboplatin
    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 Arms  ICMJE
  • Experimental: Experimental
    Intervention: Drug: CT-2103/carboplatin
  • Active Comparator: Control
    Intervention: Drug: paclitaxel/carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 14, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2007)
200
Actual Study Completion Date  ICMJE April 5, 2010
Actual Primary Completion Date April 5, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00576225
Other Study ID Numbers  ICMJE PGT307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CTI BioPharma
Study Sponsor  ICMJE CTI BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jack W. Singer, M.D. CTI BioPharma
PRS Account CTI BioPharma
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP