A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer

NCT ID: NCT00152477

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-15
• Study Completion Date: 2009-06-25

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.

Conditions

Carcinoma; Non-Squamous Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin/Paclitaxel

Carboplatin and paclitaxel alone.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin/Paclitaxel/CDP791 10mg

Carboplatin and paclitaxel plus CDP791 10mg/kg

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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 10mg/kg

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Carboplatin/Paclitaxel/CDP791 20mg

Carboplatin and paclitaxel plus CDP791 20mg/kg

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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 10mg/kg

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

Carboplatin

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

Paclitaxel

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

CDP791 10mg/kg

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

CDP791 20mg/kg

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 Type: DRUG

Other Intervention Names

CBDCA, Paraplatin, JM-8, NSC 241240; Taxol, NSC #673089

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

UCB (+1 844 599 2273)

Locations

Budapest, , Hungary

Deszk, , Hungary

Mátraháza, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Olsztyn, , Poland

Otwock, , Poland

Poznan, , Poland

Radom, , Poland

Szczecin, , Poland

Torun, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Zabrze, , Poland

Kazan', , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Countries

Hungary; Poland; Russia

Other Identifiers

C79102

Identifier Type: -

Identifier Source: org_study_id