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

Phase 3

Withdrawn

• Conditions: NSCLC
• Interventions: Drug: CT-2103/carboplatin; Drug: paclitaxel/carboplatin

• Registration Number: NCT00576225
• Lead Sponsor: CTI BioPharma

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 available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Primary Completion: 2010-04-05
• Study Completion: 2010-04-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	CT-2103/carboplatin	-
Control	paclitaxel/carboplatin	-

Primary Outcome Measures

Name	Time	Method
Survival	up to 3 years post treatment

Secondary Outcome Measures

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

Trial Locations

Locations (44)

Scottsdale Medical Specialists; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Hembree Regional Cancer Center; 🇺🇸 Fort Smith, Arkansas, United States

Providence St. Joseph Medical Center; 🇺🇸 Burbank, California, United States

Southwest Cancer Care; 🇺🇸 Escondido, California, United States

Clinical Trials & Research Institute; 🇺🇸 Montebello, California, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Broward Oncology Associates; 🇺🇸 Fort Lauderdale, Florida, United States

Horizon Institute for Clinical Research; 🇺🇸 Hollywood, Florida, United States

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