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

NCT00576225 | Withdrawn Phase 3 DMC

• 1 other identifier: PGT307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 44

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.

Conditions

NSCLC

Keywords

NSCLC; women; CT-2103; paclitaxel; carboplatin

Outcome Measures

Primary Outcomes (1)

• Survival

  up to 3 years post treatment

Secondary Outcomes (1)

• progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety

  up to 3 years post treatment

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: CT-2103/carboplatin

Control

ACTIVE COMPARATOR

Drug: paclitaxel/carboplatin

Interventions

CT-2103/carboplatin DRUG

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.

Experimental

paclitaxel/carboplatin DRUG

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CTI BioPharma: lead

Study Sites (44)

Scottsdale Medical Specialists

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Hembree Regional Cancer Center

Fort Smith, Arkansas, 72903, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

Southwest Cancer Care

Escondido, California, 92025, United States

Location

Clinical Trials & Research Institute

Montebello, California, 90640, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Horizon Institute for Clinical Research

Hollywood, Florida, 33021, United States

Location

Memorial Cancer Institute

Hollywood, Florida, 33021, United States

Location

Pasco Pinellas Cancer Center

Tarpon Springs, Florida, 34691, United States

Location

Joliet Oncology Hematology Associates, Ltd

Joliet, Illinois, 60435, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Hematology Oncology Consultants

Naperville, Illinois, 60540, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Family Medicine of Vincennes Clinical Trials Center

Vincennes, Indiana, 47591, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, 66210, United States

Location

Henry Ford Health System, Josephine Ford Cancer Center

Detroit, Michigan, 48202, United States

Location

W. Michigan Regional Cancer & Blood Center

Free Soil, Michigan, 49411, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Columbia Comprehensive Cancer Care Clinics

Jefferson City, Missouri, 65109, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Las Vegas Cancer Center

Henderson, Nevada, 89052, United States

Location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

Lincoln Medical and Mental Health Center

New York, New York, 10451, United States

Location

Arena Oncology Associates

New York, New York, 11042, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

St Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Blood and Cancer Center

Canfield, Ohio, 44406, United States

Location

Aultman Hospital Clinical Trials

Canton, Ohio, 44710, United States

Location

UIMA, Inc / University of Cincinnati-Barrett Cancer Center

Cincinnati, Ohio, 45267, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73117, United States

Location

Vita Hematology Oncology, P.C.

Fountain Hill, Pennsylvania, 18105, United States

Location

The Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Mid-South Cancer Center

Germantown, Tennessee, 38138, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Lone Star Oncology Consultants

Austin, Texas, 78759, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Cancer Outreach Associates, LLC

Arlington, Virginia, 24211, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

MeSH Terms

Interventions

CP protocol

Study Officials

• Jack W. Singer, M.D.

  CTI BioPharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: September 1, 2007
• Primary Completion: April 5, 2010
• Study Completion: April 5, 2010
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (44)