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

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-005233-35-GB
• Date of registration: 15/12/2005
• Prospective Registration: Yes
• Primary sponsor: Cell Therapeutics, Inc.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 28/03/2006
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005233-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Paclitaxel

Countries of recruitment

Hungary, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1.Female.
2.Histologically- or cytologically-confirmed diagnosis of NSCLC. (Note: Sputum cytology alone is not acceptable for cell type. Cytologic specimens obtained by brushings, washings, or needle aspiration of a defined lesion or from a pleural effusion are acceptable).
3.ECOG performance score (PS) 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 superior or equal to 18 years.
6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC) > or equal to 1,500/µL and platelet count > or equal to 100,000/µL.
7.Adequate renal function demonstrated by creatinine < or equal to 1.5 X the upper limit of normal (ULN).
8.Adequate hepatic function demonstrated by all of the following
•Total bilirubin •If liver metastases are not present, SGOT and SGPT 9.Patients with known brain metastases must have received standard antitumor treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their CNS metastases as defined by the site’s institutional standards. Neurologic function must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen. Patients must have recovered from therapy for their brain metastases.

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.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
None of the following characteristics may be present:

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:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Advanced Non-Small Cell Lung Cancer (NSCLC) in women.
MedDRA version: 5.1 Level: NOS Classification code 10029514

Intervention(s)

Product Name: Xyotax
Product Code: CT 2103
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 263351-82-2
Current Sponsor code: CT-2103
Other descriptive name: paclitaxel polyglumex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): Overall survival

Main Objective: 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.

Secondary Objective: 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.

Secondary ID(s)

PGT-305