AzTrials
AzTrials

CarcinomaPhase 2NCT00152477

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

A Phase 2 study testing Carboplatin, Paclitaxel and CDP791 10mg/kg in people with Carcinoma and Non-Squamous Non-Small-Cell Lung Cancer, run by UCB Pharma at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Paclitaxel and CDP791 10mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
21 sitesin 3 countries
Study dates
15 Aug 2005to 25 Jun 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

Poland12 sites

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Olsztyn

  • Study site

    Otwock

  • Study site

    Poznan

  • Study site

    Radom

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

  • Study site

    Zabrze

Other trials in Poland

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Deszk

  • Study site

    Mátraháza

  • Study site

    Nyíregyháza

  • Study site

    Pécs

Other trials in Hungary

Russia4 sites

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

Other trials in Russia

About this study

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

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.

Read the 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.

Being tested
Carboplatin, Paclitaxel, CDP791 10mg/kg, CDP791 20mg/kg
Keywords
Non-small-cell-lung cancer, carboplatin, paclitaxel, VEGF, monoclonal antibody
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called CBDCA, Paraplatin, JM-8, NSC 241240

    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.

  • PaclitaxelDrug

    Also called Taxol, NSC #673089

    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/kgDrug

    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/kgDrug

    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.

Study groups in NCT00152477
Study groupRoleWhat they receive
Carboplatin/PaclitaxelExperimentalCarboplatin and paclitaxel alone.
Receives: Drug: Carboplatin; Drug: Paclitaxel
Carboplatin/Paclitaxel/CDP791 10mgExperimentalCarboplatin and paclitaxel plus CDP791 10mg/kg
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: CDP791 10mg/kg; Drug: CDP791 20mg/kg
Carboplatin/Paclitaxel/CDP791 20mgExperimentalCarboplatin and paclitaxel plus CDP791 20mg/kg
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: CDP791 10mg/kg; Drug: CDP791 20mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Up to 57 weeks

  2. 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.

    Measured: Up to 57 weeks

  3. Overall Survival

    Overall survival is defined as the time from date of randomization until the date of death.

    Measured: Up to 57 weeks

  4. 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.

    Measured: Up to 57 weeks

  5. 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).

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2005 (estimated)
  2. Study start15 Aug 2005
  3. Primary completion25 Jun 2009
  4. Study completion25 Jun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00152477
Sponsor's protocol ID
C79102
Status last verified
Apr 2022
First submitted
6 Sep 2005
Last updated
12 Apr 2022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and CDP791 10mg/kg in people with Carcinoma and Non-Squamous Non-Small-Cell Lung Cancer, run by UCB Pharma at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Poland, Hungary, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response Rate (RR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00152477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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