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Carcinoma, Non-Small-Cell LungPhase 1/2PECASONCT00473486

Study in Patients With Advanced Non-Small Cell Lung Cancer Treated With Pemetrexed and Carboplatin Plus or Minus Sorafenib

A Phase 1/2 study testing pemetrexed, carboplatin, sorafenib in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital Muenster at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The majority of patients with advanced NSCLC treated with standard platinum based chemotherapy regimens ultimately develop disease progression. Active therapies with improved toxicity profiles are clearly needed in this setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
pemetrexed, carboplatin, sorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteGermany
Study dates
May 2007to Jan 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed NSCLC
  • Locally advanced (stage IIIB with malignant pleural or pericardial effusion) or metastatic (stage IV) NSCLC
  • No prior systemic chemotherapy
  • Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study medication; also concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed
  • Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study medication and patient should be fully recovered.
  • Must have measurable disease with at least one lesion with a longest diameter measured as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT
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  • Age ≥18 years old
  • ECOG performance score (PS) 0-1
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, renal and hepatic function
  • hemoglobin ≥ 9.0 g/dl
  • absolute neutrophil count ≥1,500/mm3
  • platelet count ≥ 100,000/mm3
  • total bilirubin ≤ 1.5 times the upper limit of normal
  • ALT and AST ≤ 2.5 times the upper limit of normal (≤ 5 x upper limit of normal for patients with liver involvement)
  • INR ≤ 1.5 and aPTT within normal limits
  • serum creatinine ≤ 1.5 the upper limit of normal
  • Patients with creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing patients
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib
  • Signed informed consent prior to any study specific procedures
  • Compliance and geographic proximity that allow adequate follow-up

Who cannot join

  • Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy (treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC
  • Any participation in a clinical trial 30 days prior to study entry and concomitantly to the study
  • Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (angina symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  • Documented brain metastases (unless the patient is > 6 months from definitive therapy for brain metastases, has a negative imaging study within 4 weeks of study entry and has been off corticosteroids for at least 4 weeks before study enrolment). Brain imaging (CT scan/MRI) is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
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  • Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
  • Known HIV infection or chronic hepatitis B or C
  • Active clinically serious infections > CTCAE Grade 2
  • Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study enrolment
  • Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug
  • Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first dose of study drug
  • Evidence or history of bleeding diathesis or coagulopathy
  • Therapeutic anticoagulation with vitamin K antagonists such as phenprocoumon, warfarin, or with heparins or heparinoids. Low dose anticoagulation is permitted
  • Serious, non-healing wound, ulcer, or bone fracture
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug
  • Known or suspected allergy to sorafenib, carboplatin or pemetrexed
  • Previous or current cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry
  • Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study
  • Significant weight loss (> or equal 10% body weight during preceeding 6 weeks)
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
  • Recent (within 30 days of enrolment) or concurrent yellow fever vaccination
  • Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Muenster, Dept. of Medicine, Hematology / Oncology

    Münster, 48145

Other trials in Germany

About this study

Official title: A Randomized (PhaseII), Double-blind, Multicenter Phase I/II Trial of Pemetrexed, Carboplatin Plus or Minus Sorafenib in the First-line Treatment of Patients With Stage IIIb or IV Non-Small Cell Lung Cancer

The majority of patients with advanced NSCLC treated with standard platinum based chemotherapy regimens ultimately develop disease progression. Active therapies with improved toxicity profiles are clearly needed in this setting. The primary objective of this trial is to assess the toxicity profile and to determine the effect on progression free survival and time to progression in patients with advanced NSCLC treated with sorafenib in addition to carboplatin and pemetrexed.

Being tested
pemetrexed, carboplatin, sorafenib, pemetrexed, carboplatin, placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • pemetrexed, carboplatin, sorafenibDrug

    Ph. 1: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; Sorafenib 200mg po bid days 2-19; 400mg po bid days 2-19

    Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1;sorafenib depending on results of Ph 1

  • pemetrexed, carboplatin, placeboDrug

    Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; placebo day 2-19

Study groups in NCT00473486
Study groupRoleWhat they receive
1Active comparatorPemetrexed, Carboplatin plus Sorafenib in the first-line treatment of patients with stage IIIb or IV NSCLC
Receives: Drug: pemetrexed, carboplatin, sorafenib
2Placebo comparatorPemetrexed, Carboplatin plus placebo in the first-line treatment of patients with stage IIIb or IV NSCLC
Receives: Drug: pemetrexed, carboplatin, placebo

What is being measured

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

  1. Ph.1: Identify the recommended phase II dose of sorafenib for combination therapy with carboplatin and pemetrexed

    Measured: July 2008

  2. Ph.2: Compare the PFS of carboplatin/pemetrexed + sorafenib or carboplatin/pemetrexed + placebo in patients with stage IIIb or IV non-small cell lung cancer

    Measured: May 2009

Secondary outcomes (10)

  1. Ph.1: Determine dose limiting toxicity

    Measured: July 2008

  2. Ph 1: Determine the safety profile of the combination treatment

    Measured: July 2008

  3. Ph 1: descriptive analysis of efficacy

    Measured: July 2008

  4. Ph.2: Compare PFS of carboplatin/pemetrexed + sorafenib or carboplatin/pemetrexed + placebo in patients with stage IIIb or IV NSCLC

    Measured: May 2009

  5. Ph 2: Assess time to progression in patients treated with either regimen

    Measured: May 2009

  6. Ph 2: Determine the overall survival in patients treated with either regimen

    Measured: May 2009

  7. Ph 2: Determine the objective response rate (CR, PR), disease control rate (CR,PR,SD), time to response and duration of response

    Measured: May 2009

  8. Ph 2: Identify surrogate markers from the tumor biopsy or resection specimen from the time of diagnosis that predict response

    Measured: May 2009

  9. Ph 2: Assess Quality of Life of patients treated with either regimen

    Measured: May 2009

  10. Ph 2: Assess feasibility and toxicity profile of this regimen

    Measured: May 2009

Timeline

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

  1. First posted15 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2008
  4. Study completionJan 2010

Why it stopped: Sorafenib administered in the combination with pemetrexed-carboplatin appears to enhance thrombocytopenia compared to historical data.

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473486
Sponsor's protocol ID
2006-005970-26
Other IDs
KKS / INNERE_A / NSCLC2006
Acronym
PECASO
Status last verified
Jun 2007
First submitted
14 May 2007
Last updated
27 Jan 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pemetrexed, carboplatin, sorafenib in people with Carcinoma, Non-Small-Cell Lung, run by University Hospital Muenster at 1 site in Germany.

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 23 inclusion and 24 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: stopped early, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Sorafenib administered in the combination with pemetrexed-carboplatin appears to enhance thrombocytopenia compared to historical data.). Results are not available in the source record.

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?

Ph.1: Identify the recommended phase II dose of sorafenib for combination therapy with carboplatin and pemetrexed (time frame: July 2008). The study lists 2 primary outcomes in all. 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 NCT00473486.

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 27 Jan 2010.

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