Status:
TERMINATED
A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
Lead Sponsor:
CTI BioPharma
Conditions:
NSCLC
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 ad...
Detailed Description
See Summary
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00269828
Start Date
December 1 2005
End Date
December 1 2006
Last Update
November 24 2020
Active Locations (143)
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1
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85222
2
Arizona Hematology Oncology
Tucson, Arizona, United States, 85704
3
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
4
Heritage Physician Group, Oncology
Hot Springs, Arkansas, United States, 71913