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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00152477
First received: September 6, 2005
Last updated: September 2, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Carcinoma
Non-Squamous Non-Small-Cell Lung Cancer
Drug: Carboplatin
Drug: Paclitaxel
Drug: CDP791 10mg/kg
Drug: CDP791 20mg/kg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Tumour response rate at 18 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: at specified % event rates ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at specified % event rates ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: analyzed alongside other parameters ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboplatin/Paclitaxel
Carboplatin and paclitaxel alone.
Drug: 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.

Other Name: CBDCA, Paraplatin, JM-8, NSC 241240
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.
Other Name: Taxol, NSC #673089
Experimental: Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin and paclitaxel plus CDP791 10mg/kg
Drug: 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.

Other Name: CBDCA, Paraplatin, JM-8, NSC 241240
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.
Other Name: Taxol, NSC #673089
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.
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.
Experimental: Carboplatin/Paclitaxel/CDP791 20mg
Carboplatin and paclitaxel plus CDP791 20mg/kg
Drug: 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.

Other Name: CBDCA, Paraplatin, JM-8, NSC 241240
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.
Other Name: Taxol, NSC #673089
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152477

Locations
Hungary
Budapest, Hungary
Deszk, Hungary
Matrahaza, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Olsztyn, Poland
Otwock, Poland
Poznan, Poland
Radom, Poland
Szczecin, Poland
Torun, Poland
Warszawa, Poland
Wroclaw, Poland
Zabrze, Poland
Russian Federation
Kazan, Russian Federation
Moscow, Russian Federation
Moskow, Russian Federation
Saint Petersburg, Russian Federation
Samara, Russian Federation
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00152477     History of Changes
Other Study ID Numbers: C79102, EudraCT 2005-001731-30
Study First Received: September 6, 2005
Last Updated: September 2, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by UCB Pharma:
Non-small-cell-lung cancer
carboplatin
paclitaxel
VEGF
monoclonal antibody

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014