Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003807

Trial Description

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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

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Trial Acronym

PECASO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003807
  •   2012/07/03
  •   2007/05/14
  •   yes
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Secondary IDs

  •   2006-005970-26 
  •   NCT00473486  (ClinicalTrials.gov)
  •   2006-005970-26  (University Hospital Muenster)
  •   KKS / INNERE_A / NSCLC2006 
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Health Condition or Problem studied

  •   Carcinoma, Non-Small-Cell Lung
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: pemetrexed, carboplatin, sorafenib
  •   Drug: pemetrexed, carboplatin, placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   I-II
  •   [---]*
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Primary Outcome

- Ph.1: Identify the recommended phase II dose of sorafenib for combination therapy with carboplatin and pemetrexed; time frame: July 2008
- 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; time frame: May 2009

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Secondary Outcome

- Ph.1: Determine dose limiting toxicity; time frame: July 2008
- Ph 1: Determine the safety profile of the combination treatment; time frame: July 2008
- Ph 1: descriptive analysis of efficacy; time frame: July 2008
- Ph.2: Compare PFS of carboplatin/pemetrexed + sorafenib or carboplatin/pemetrexed + placebo in patients with stage IIIb or IV NSCLC; time frame: May 2009
- Ph 2: Assess time to progression in patients treated with either regimen; time frame: May 2009
- Ph 2: Determine the overall survival in patients treated with either regimen; time frame: May 2009
- Ph 2: Determine the objective response rate (CR, PR), disease control rate (CR,PR,SD), time to response and duration of response; time frame: May 2009
- Ph 2: Identify surrogate markers from the tumor biopsy or resection specimen from the time of diagnosis that predict response; time frame: May 2009
- Ph 2: Assess Quality of Life of patients treated with either regimen; time frame: May 2009
- Ph 2: Assess feasibility and toxicity profile of this regimen; time frame: May 2009

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Planned
  •   2007/05/31
  •   12
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- 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

- 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

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Exclusion Criteria

- 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.

- 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.

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Addresses

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    • University Hospital Muenster
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    • Universitätsklinikum Münster, Med. Klinik und Poliklinik A, Hämatologie, Onkologie und Pneumologie and Uniklinik Frankfurt Innere Medizin, Hämatologie/Onkologie, 60590 Frankfurt
    • Christian Brandts, MD 
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    • Universitätsklinikum Münster, Med. Klinik und Poliklinik A, Hämatologie, Onkologie und Pneumologie and Uniklinik Frankfurt Innere Medizin, Hämatologie/Onkologie, 60590 Frankfurt
    • Christian Brandts, MD 
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Sources of Monetary or Material Support

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Status

  •   Recruiting stopped after recruiting started
  •   2010/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.