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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00269828 |
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Date of registration:
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22/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
PIONEER |
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Scientific title:
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Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2. |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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600 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00269828 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Bulgaria
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Canada
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Hungary
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Mexico
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Poland
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Romania
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Russian Federation
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Ukraine
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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NSCLC
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Intervention(s)
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Drug: paclitaxel poliglumex
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Drug: paclitaxel
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Primary Outcome(s)
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The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.
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Secondary Outcome(s)
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Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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