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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00576225
• Date of registration: 17/12/2007
• Primary sponsor: Cell Therapeutics
• Public title: CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 450
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00576225
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jack W. Singer, M.D.
• Affiliation: Cell Therapeutics

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

NSCLC

Intervention(s)

Drug: CT-2103/carboplatin

Drug: paclitaxel/carboplatin

Primary Outcome(s)

Survival [Time Frame: up to 3 years post treatment]

Secondary Outcome(s)

progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety [Time Frame: up to 3 years post treatment]

Secondary ID(s)

PGT307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors