Paclitaxel poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 30 pg/ml

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004167-22-HU
• Date of registration: 20/11/2007
• Prospective Registration: Yes
• Primary sponsor: Cell Therapeutics, Inc.
• Public title: Paclitaxel poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 30 pg/ml
• Scientific title: Paclitaxel poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 30 pg/ml
• Date of first enrolment: 23/01/2008
• Target sample size: 450
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004167-22
• 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: no

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
1. Women with baseline estradiol >30 pg/mL (Women on hormone replacement therapy are allowed if baseline estradiol >30 pg/mL).
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). Patients may have either measurable or nonmeasurable
disease according to RECIST.
3. ECOG performance score (PS) of 0, 1, or 2 defined as:
0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out
work of a light or sedentary nature, e.g., light house work, office work
2 = Ambulatory and capable of all self-care but unable to carry out any work
activities and up and about more than 50% of waking hours.
4. Patients must meet one of the following criteria:
• Recurrent disease following completion of radiation or surgery
• Stage IIIB who are not candidates for combined modality therapy (primary
radiation therapy or surgery), or
• Stage IV.
5. Age =18 years.
6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC)
=1.5X 109/L and platelet count =100 X 109/L.
7. Hemoglobin =10 g/dL (may be achieved with transfusion).
8. Adequate renal function demonstrated by creatinine = 1.5 X the upper limit of normal (ULN).
9. Adequate hepatic function demonstrated by all of the following
• Total bilirubin = 1.5 ULN (CTC grade 1) (patients with Gilbert’s Syndrome or
other hereditary bilirubin defects may be included regardless of bilirubin levels)
and
• If liver metastases are not present, SGOT and SGPT =2.5 x ULN (CTC grade 0
or 1), otherwise SGOT and SGPT must be =5 x ULN (CTC grade 0 to 2).
• Alkaline phosphatase less than or equal to 2.5 x ULN except for elevated
alkaline phosphatase with laboratory documentation that demonstrates bone
origin.
10. Life expectancy =12 weeks
11. 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.
12. Patients who have had major surgery must be fully recovered from the surgery.
13. Ability to comply with the visit schedule and assessments required by the protocol.
14. For patients of reproductive potential, commitment to use adequate contraception during the study and for 6 months after the last dose of study drug.
15. Signed approved informed consent, with understanding of study procedures including follow-up for survival.
16. 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:
1. ECOG performance score (PS) of 0, 1, 3, or 4 defined as:
3 = Capable of only limited self-care, confined to bed or chair more than 50% of
waking hours
4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or
chair
2. Known hypersensitivity to the excipients or the study drug (either CT-2103,
paclitaxel, or carboplatin that the patient will receive.
3. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology.
4. Weight loss >10% in previous 6 months
5. LDH > 600 IU/L (central laboratory) regardless of weight loss
6. Both LDH > 400 IU/L (central laboratory) and = 5% weight loss in previous 6
months
7. BMI >35
8. Any prior systemic chemotherapy for the treatment of lung cancer. This includes
systemic radiosensitizers used to treat brain metastases and any biologic agent.
9. Local palliative radiotherapy < 7 days before randomization.
10. Radiation with curative intent < 30 days before randomization.
11. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
12. Grade 2 or greater neuropathy.
13. 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 10).
14. Clinically significant active infection for which active therapy is underway.
15. Investigational therapy within 4 weeks before randomization, unless local
requirements are more stringent.
16. 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.
17. Pregnant women or nursing mothers.
18. 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: 9.1 Level: LLT Classification code 10029515 Term: Non-small cell lung cancer recurrent
MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV

Intervention(s)

Product Name: Paclitaxel poliglumex
Product Code: CT-2103
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: paclitaxel poliglumex
CAS Number: 263351-82-2
Other descriptive name: ester conjugate of alpha-poly-L-glutamic acid and paclitaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 9-

Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: paclitaxel
Other descriptive name: Taxol, Anzatax, Asotax, Bristaxol, Praxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 6-

Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: carboplatin
CAS Number: 41575-94-4
Other descriptive name: Paraplatin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: To compare the progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety and tolerability of the treatment arms.

Main Objective: To compare the overall survival of patients randomized to the CT-2103/carboplatin arm to that of patients randomised to the comparator arm (paclitaxel/carboplatin).

Primary end point(s): Overall Survival: The interval between the date of randomization and death due to
any cause. The overall survival for patients who are alive at their date of last
contact, including those lost to follow-up, will be censored at the date of last
contact.

Secondary ID(s)

PGT307