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

Not Recruiting

Trial ID: NCT00576225


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.

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


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

   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

11. Grade 2 or greater neuropathy.

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

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.


drug: CT-2103/carboplatin

drug: paclitaxel/carboplatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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