Back to resultsA Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
Primary Purpose
Carcinoma, Non-Squamous Non-Small-Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
CDP791 10mg/kg
CDP791 20mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Non-small-cell-lung cancer, carboplatin, paclitaxel, VEGF, monoclonal antibody
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma. The subject must be aged 18 years or above. The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months. Subjects will have measurable disease. The subject must be able to understand the information provided to them and to give written informed consent. Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator. Male subjects must be using a method of contraception judged reliable by the Investigator. Exclusion Criteria: Subjects with squamous cell lung carcinoma. Subjects with lung lesions located centrally in the chest that involve major blood vessels. Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more. Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy. Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2. Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent). Exclusion Criteria:
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Carboplatin/Paclitaxel
Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin/Paclitaxel/CDP791 20mg
Arm Description
Carboplatin and paclitaxel alone.
Carboplatin and paclitaxel plus CDP791 10mg/kg
Carboplatin and paclitaxel plus CDP791 20mg/kg
Outcomes
Primary Outcome Measures
Tumor Response Rate (RR)
Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = >=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS):
(CR + PR) / RS.
Secondary Outcome Measures
Progression Free Survival (PFS)
Progression free survival (PFS) is defined as time from date of randomization until the date progressive disease (PD) is first recorded or until death, whichever is first.
Time to Treatment Failure
Time to treatment failure (TTF) is defined as the time from date of randomization until the date of progression, death or, for subjects who discontinued treatment for toxicity reason, their last dosing date, whichever occurs first.
Overall Survival
Overall survival is defined as the time from date of randomization until the date of death.
Duration of Overall Response
The duration of overall response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR), whichever is recorded first, until the first date of documented progressive disease or death.
Time to Response
Time to response is defined as the time from the first dose of study therapy until measurement criteria are first met for complete response or partial response (whichever is recorded first).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00152477
Brief Title
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
Official Title
A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2005 (Actual)
Primary Completion Date
June 25, 2009 (Actual)
Study Completion Date
June 25, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
Detailed Description
This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.
In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.
If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.
Participants will be followed up longterm, so that survival can be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Squamous Non-Small-Cell Lung Cancer
Keywords
Non-small-cell-lung cancer, carboplatin, paclitaxel, VEGF, monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carboplatin/Paclitaxel
Arm Type
Experimental
Arm Description
Carboplatin and paclitaxel alone.
Arm Title
Carboplatin/Paclitaxel/CDP791 10mg
Arm Type
Experimental
Arm Description
Carboplatin and paclitaxel plus CDP791 10mg/kg
Arm Title
Carboplatin/Paclitaxel/CDP791 20mg
Arm Type
Experimental
Arm Description
Carboplatin and paclitaxel plus CDP791 20mg/kg
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
CBDCA, Paraplatin, JM-8, NSC 241240
Intervention Description
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle.
Each cycle to be repeated every three weeks for a maximum of six cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, NSC #673089
Intervention Description
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
CDP791 10mg/kg
Intervention Description
CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Intervention Type
Drug
Intervention Name(s)
CDP791 20mg/kg
Intervention Description
CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
Primary Outcome Measure Information:
Title
Tumor Response Rate (RR)
Description
Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = >=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS):
(CR + PR) / RS.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression free survival (PFS) is defined as time from date of randomization until the date progressive disease (PD) is first recorded or until death, whichever is first.
Time Frame
Up to 57 weeks
Title
Time to Treatment Failure
Description
Time to treatment failure (TTF) is defined as the time from date of randomization until the date of progression, death or, for subjects who discontinued treatment for toxicity reason, their last dosing date, whichever occurs first.
Time Frame
Up to 57 weeks
Title
Overall Survival
Description
Overall survival is defined as the time from date of randomization until the date of death.
Time Frame
Up to 57 weeks
Title
Duration of Overall Response
Description
The duration of overall response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR), whichever is recorded first, until the first date of documented progressive disease or death.
Time Frame
Up to 57 weeks
Title
Time to Response
Description
Time to response is defined as the time from the first dose of study therapy until measurement criteria are first met for complete response or partial response (whichever is recorded first).
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
The subject must be aged 18 years or above.
The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
Subjects will have measurable disease.
The subject must be able to understand the information provided to them and to give written informed consent.
Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
Male subjects must be using a method of contraception judged reliable by the Investigator.
Exclusion Criteria:
Subjects with squamous cell lung carcinoma.
Subjects with lung lesions located centrally in the chest that involve major blood vessels.
Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2.
Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
City
Budapest
Country
Hungary
City
Deszk
Country
Hungary
City
Matrahaza
Country
Hungary
City
Nyiregyhaza
Country
Hungary
City
Pecs
Country
Hungary
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Olsztyn
Country
Poland
City
Otwock
Country
Poland
City
Poznan
Country
Poland
City
Radom
Country
Poland
City
Szczecin
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Zabrze
Country
Poland
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Moskow
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Samara
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
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