Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005394

Trial Description

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Title

Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed Versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell Lung Cancer (NSCLC)

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Trial Acronym

PemSplitCisp

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URL of the Trial

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Brief Summary in Lay Language

Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced
and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth
factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of
a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and
often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on
Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing
chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable
toxicity profiles and generally with an excellent patient compliance.

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Brief Summary in Scientific Language

There is a current need to develop a split-dose cisplatinum regimen in combination with
pemetrexed with high efficacy, excellent treatment compliance, administration convenience
and the possibility to open up easier outpatient administration of the chemotherapy
protocol. Dosing of cisplatinum at 40 mg/m2 d 1 and day 8 seems to be very effective and
useful for this strategy. The current trial will address this issue within a prospective
randomized phase-II trial. Treatment will be given on day 1 and 8 in the split-dose arm. A
comparator arm of the current three-weekly higher cisplatinum schedule will be added to this
study. For evaluation of this strategy observation of the toxicity/efficacy ratio within
this trial will be of major importance. Efficacy will be analyzed by objective response
rate, symptom control and life-quality. Toxicity will be looked at with treatment toxicity,
treatment compliance and adherence to protocol.

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Organizational Data

  •   DRKS00005394
  •   2014/04/17
  •   2012/12/03
  •   yes
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Secondary IDs

  •   2011-001963-37 
  •   NCT01742767  (ClinicalTrials.gov)
  •   2011-001963-37  (Universität Duisburg-Essen)
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Health Condition or Problem studied

  •   NSCLC
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: Cisplatinum
  •   Drug: Pemetrexed
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Characteristics

  •   Interventional
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Response rate; time frame: 3 years

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2012/11/30
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  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Patients are eligible to be included in the study only if they meet all of the
following criteria:

1. Histologically or cytologically confirmed diagnosis of non-squamous-cell
non-small cell lung cancer (NSCLC) Stage IV (American Joint Committee on Cancer
Staging Criteria [AJCC], Version 7, 2009)

2. No prior systemic chemotherapy for lung cancer

3. At least one unidimensionally measurable lesion meeting Response Evaluation
Criteria in Solid Tumours (RECIST; version 1.1, Eisenhauer et al. 2009), longest
diameter ≥10 mm with computed tomography (CT) scan [CT scan slice thickness no
greater than 5 mm] , or ≥ 20 mm with chest x-ray. Positron emission tomography
(PET) scans and ultrasounds should not be used.

4. ECOG performance status of 0 or 1 (Oken et al. 1982)

5. ≥ 18 years of age < 75 years

6. Adequate organ function,

7. Prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman
1987). Prior radiation to the whole pelvis is not allowed. Prior radiotherapy
must be completed at least 4 weeks before study enrollment. Patients must have
recovered from the acute toxic effects of the treatment prior to study
enrollment.

8. Patient must understand and sign an informed consent document before the start
of specific protocol procedures.

9. A pretreatment FFPE tumour biopsy must be available for central biomarker
analysis. If consented by the patient and clinically feasible, a fresh
pretreatment biopsy is obtained and submitted for central biomarker analysis.

10. Female patients with childbearing potential must use highly effective methods of
contraception (combined oral contraceptives, hormon-releasing intrauterine
contraceptive device, hormonal contraceptive implants, hormonal contraceptive
injectables) or have sexual intercourse with a vasectomised partner only during
and for 6 months after the study and their pregnancy test must be negative
within 7 days prior to study enrollment.

A female subject is considered to be of childbearing potential unless she is age
≥ 50 years and naturally amenorrhoeic for ≥ 2 year or unless she is surgically
sterile.

Male patients must agree to use condoms during the study and for 6 months after
the study if their partner is of childbearing potential and does not use highly
effective method of contraception.

11. Estimated life expectancy of 12 weeks

12. Patient compliance and geographic proximity that allow adequate follow up.

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Exclusion Criteria

- Patients will be excluded from the study if they meet any of the following criteria:

1. Active participation in other clinical studies or treatment with any
experimental drug within 30 days prior to study enrollment or during study
participation.

2. Patients with known somatic activating mutations of EGFR, as these patients
should be offered EGFR- tyrosine kinase inhibitor (EGFR-TKI) treatment as
first-line therapy. Detection of EGFR mutations and additional somatic mutations
with relation to treatment will be performed centrally at the
Universitätsklinikum Essen. In case immediate treatment initiation is required
for medical reasons (such as superior vena cava syndrome, severely symptomatic
disease) patients may be enrolled before results from EGFR testing are
available. As EGFR-TKI treatment is equally effective in second-line therapy,
such patients may remain on study treatment if a clinical benefit is derived.

3. Peripheral neuropathy of ³CTCAE Grade 1

4. Inability to comply with protocol or study procedures

5. A serious concomitant systemic disorder that, in the opinion of the
investigator, would compromise the patient's ability to complete the study.

6. A serious cardiac condition, such as myocardial infarction within 6 months prior
to study enrollment, symptomatic coronary artery disease, cardiac arrhythmia, or
other heart disease, as defined by the New York Heart Association Class III or
IV (functional capacity)

7. Second primary malignancy that is clinically detectable at the time of
consideration for study enrollment

8. Documented brain metastases unless the patient has completed successful local
therapy for central nervous system metastases and has been off of
corticosteroids for at least 4 weeks before enrollment. Brain imaging is
required in symptomatic patients to rule out brain metastases,but is not
required in asymptomatic patients

9. The effect of third space fluid, such as pleural effusion and ascites, on
pemetrexed is unknown. In patients with clinically significant third space
fluid, consideration should be given to draining the effusion prior to
pemetrexed administration.

10. Significant weight loss (that is 10%) over the previous 6 weeks before study
entry

11. Significant hearing function impairment, especially high-frequency hearing
function impairment

12. Any active or uncontrolled infection

13. Concurrent administration of any other antitumour therapy

14. 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)

15. Inability or unwillingness to take folic acid or vitamin B12 supplementation

16. Inability to take corticosteroids

17. Hypersensitivity to cisplatinum or to any other platinum compound

18. Hypersensitivity to pemetrexed or to any of the excipients of ALIMTA®

19. Pregnant or breast-feeding patient

20. Yellow fever vaccination within the 30 days previous to study entry.

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Addresses

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    • Universität Duisburg-Essen
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    • Eli Lilly and Company
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    • Universital hospital essen
    • Wilfried Eberhardt, MD 
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    • Wilfried Eberhardt, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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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 .
  •   117
  •   2013/10/22
* This entry means the parameter is not applicable or has not been set.