Overview

This trial is active, not recruiting.

Condition nsclc
Treatments ct-2103/carboplatin, paclitaxel/carboplatin
Phase phase 3
Sponsor CTI BioPharma
Start date September 2007
End date January 2014
Trial size 450 participants
Trial identifier NCT00576225, PGT307

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Survival
time frame: up to 3 years post treatment

Secondary Outcomes

Measure
progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety
time frame: up to 3 years post treatment

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria

  • 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
  • Adequate renal function
  • Adequate hepatic function
  • Life expectancy ≥12 weeks

Exclusion Criteria

  • 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
  • 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by CTI BioPharma.