A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
Condition: Carcinoma; Non-Squamous Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; Paclitaxel; CDP791 10mg/kg; CDP791 20mg/kg
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.; 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.; 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.; 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.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small-cell-lung cancer; carboplatin; paclitaxel; VEGF; monoclonal antibody

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.
    

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: