WithdrawnPhase 3NCT00576225

CT-2103/Carboplatin vs Paclitaxel/Carboplatin for 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.

Checked against the public recordLast updated Oct 19, 2020 · Source: ClinicalTrials.gov

StatusWithdrawn
PhasePhase 3
U.S. locations44
SponsorCTI BioPharma
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
CTI BioPharma
Interventions being studied
Drug: CT-2103/carboplatin; Drug: paclitaxel/carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Scottsdale Medical SpecialistsScottsdale, Arizona
  • Mayo ClinicScottsdale, Arizona
  • Hembree Regional Cancer CenterFort Smith, Arkansas
  • Providence St. Joseph Medical CenterBurbank, California
  • Southwest Cancer CareEscondido, California
  • Clinical Trials & Research InstituteMontebello, California
  • Stanford Cancer CenterStanford, California
  • Hartford HospitalHartford, Connecticut
  • Broward Oncology AssociatesFort Lauderdale, Florida
  • Horizon Institute for Clinical ResearchHollywood, Florida
  • Memorial Cancer InstituteHollywood, Florida
  • Pasco Pinellas Cancer CenterTarpon Springs, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2020. Always confirm current availability with the study team.

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