A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.

Stopped early · Phase 3

Conditions studied: NSCLC

In brief

This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle

Key facts

Study ID

NCT00269828

Run by

CTI BioPharma

People needed

600

Starts

2005-12-01

Expected to finish

2006-12-01

Last updated by the study team

2020-11-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female.
• Histologically- or cytologically-confirmed diagnosis of NSCLC.
• ECOG performance score of 2.
• Patients who meet one of the following criteria:
• Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
• Stage IV.
• Age greater than or equal to 18 years.
• Adequate bone marrow function
• Adequate renal function
• Adequate hepatic function
• Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
• Patients who have had major surgery must be fully recovered from the surgery.
• Ability to comply with the visit schedule and assessments required by the protocol.
• For patients of reproductive potential, commitment to use adequate contraception.
• Signed approved informed consent, with understanding of study procedures.
• Agreement to begin study therapy within 8 calendar days after randomization.

You may not qualify if…

• Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
• Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
• Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
• 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. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9).
• 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. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
• Pregnant women or nursing mothers.
• Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Where it is running

• Arizona Hematology Oncology — Tucson, Arizona, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Heritage Physician Group, Oncology — Hot Springs, Arkansas, United States
• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Providence St. Joseph Medical Center — Burbank, California, United States
• Hematology/Oncology Group of Fresno, Inc — Fresno, California, United States
• Comprehensive Cancer Center-Research Office — Glendale, California, United States
• Loma Linda University Cancer Institute — Loma Linda, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• The Cancer Research and Prevention Center — Soquel, California, United States
• Bethesda Research Center — Boynton Beach, Florida, United States
• Broward Oncology Associates — Fort Lauderdale, Florida, United States
• Florida Wellcare — Inverness, Florida, United States
• Cancer & Blood Disease Center — Lecanto, Florida, United States
• Oncology-Hematology Associates of West Broward — Tamarac, Florida, United States
• Hematology Oncology Speaclist — Tampa, Florida, United States
• Joliet Oncology Hematology Associates, Ltd. — Joliet, Illinois, United States
• Loyola University Health Systems — Maywood, Illinois, United States
• Mid-Illinois HEM & ONC Assoc. — Normal, Illinois, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Associated Physicians & Surgeons Clinic — Terre Haute, Indiana, United States
• Desert Oasis Cancer Center — Casa Grande, Arizona, United States

Full record on ClinicalTrials.gov

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