TerminatedPhase 3NCT00269828

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

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

Checked against the public recordLast updated Nov 24, 2020 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 3
U.S. locations143
SponsorCTI BioPharma
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
CTI BioPharma
Interventions being studied
Drug: paclitaxel; Drug: paclitaxel poliglumex
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Female. 2. Histologically- or cytologically-confirmed diagnosis of NSCLC. 3. ECOG performance score of 2. 4. 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. 5. Age greater than or equal to 18 years. 6. Adequate bone marrow function 7. Adequate renal function 8. Adequate hepatic function 9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards. 10. Patients who have had major surgery must be fully recovered from the surgery. 11. Ability to comply with the visit schedule and assessments required by the protocol. 12. For patients of reproductive potential, commitment to use adequate contraception. 13. Signed approved informed consent, with understanding of study procedures. 14. Agreement to begin study therapy within 8 calendar days after randomization. Exclusion Criteria: 1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. Grade 2 or greater neuropathy. 6. 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). 7. Clinically significant active infection for which active therapy is underway. 8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. 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. 10. Pregnant women or nursing mothers. 11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Desert Oasis Cancer CenterCasa Grande, Arizona
  • Arizona Hematology OncologyTucson, Arizona
  • Genesis Cancer CenterHot Springs, Arkansas
  • Heritage Physician Group, OncologyHot Springs, Arkansas
  • Pacific Cancer Medical Center, IncAnaheim, California
  • Comprehensive Blood and Cancer CenterBakersfield, California
  • Tower Cancer Research FoundationBeverly Hills, California
  • Providence St. Joseph Medical CenterBurbank, California
  • Hematology/Oncology Group of Fresno, IncFresno, California
  • Comprehensive Cancer Center-Research OfficeGlendale, California
  • Loma Linda University Cancer InstituteLoma Linda, California
  • Pacific Shores Medical GroupLong Beach, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 24, 2020. Always confirm current availability with the study team.

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