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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00576225
• Other study ID #: PGT307
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: April 5, 2010

Study information

• Verified date: October 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 5, 2010
• Est. primary completion date: April 5, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cancer Outreach Associates, LLC	Arlington	Virginia
United States	Lone Star Oncology Consultants	Austin	Texas
United States	Southwest Regional Cancer Center	Austin	Texas
United States	St Alexius Medical Center	Bismarck	North Dakota
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Blood and Cancer Center	Canfield	Ohio
United States	Aultman Hospital Clinical Trials	Canton	Ohio
United States	UIMA, Inc / University of Cincinnati-Barrett Cancer Center	Cincinnati	Ohio
United States	The Family Cancer Center	Collierville	Tennessee
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Henry Ford Health System, Josephine Ford Cancer Center	Detroit	Michigan
United States	Southwest Cancer Care	Escondido	California
United States	Broward Oncology Associates	Fort Lauderdale	Florida
United States	Hembree Regional Cancer Center	Fort Smith	Arkansas
United States	Vita Hematology Oncology, P.C.	Fountain Hill	Pennsylvania
United States	W. Michigan Regional Cancer & Blood Center	Free Soil	Michigan
United States	Mid-South Cancer Center	Germantown	Tennessee
United States	Hartford Hospital	Hartford	Connecticut
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Las Vegas Cancer Center	Henderson	Nevada
United States	Horizon Institute for Clinical Research	Hollywood	Florida
United States	Memorial Cancer Institute	Hollywood	Florida
United States	Columbia Comprehensive Cancer Care Clinics	Jefferson City	Missouri
United States	Joliet Oncology Hematology Associates, Ltd	Joliet	Illinois
United States	Loyola University	Maywood	Illinois
United States	Clinical Trials & Research Institute	Montebello	California
United States	Hematology Oncology Consultants	Naperville	Illinois
United States	Cancer Care Center	New Albany	Indiana
United States	Arena Oncology Associates	New York	New York
United States	Lincoln Medical and Mental Health Center	New York	New York
United States	Northern Utah Associates	Ogden	Utah
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Kansas City Cancer Center	Overland Park	Kansas
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	St. Louis University	Saint Louis	Missouri
United States	Mayo Clinic	Scottsdale	Arizona
United States	Scottsdale Medical Specialists	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California
United States	Richmond University Medical Center	Staten Island	New York
United States	Pasco Pinellas Cancer Center	Tarpon Springs	Florida
United States	Providence Medical Group	Terre Haute	Indiana
United States	New York Medical College	Valhalla	New York
United States	Family Medicine of Vincennes Clinical Trials Center	Vincennes	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		up to 3 years post treatment
Secondary	progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety		up to 3 years post treatment