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Randomized, Phase II,Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Non Small Cell Lung Carcinoma

Thank you

Trial Information

Randomized, Phase II,Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine


Inclusion Criteria:



- Written informed consent provided prior to any screening procedure

- Male or female,> 18 years of age

- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer

- Demonstrated progressive disease on or after first-line chemotherapy for stage
IIIB/IV disease. The first-line therapy must consist of platinum-based regimens in
combination with taxanes,gemcitabine or vinorelbine.. Stage IIIB/IV patients must
have measurable disease (tumor) without clinically significant pleural unless the
pleural effusion can be effectively drained prior to admission into the study.

- A chemotherapy-free interval of at least 3 weeks between the end of first-line
chemotherapy and start of study treatment

- At least 1 measurable lesion according to the modified WHO criteria

- Archived tissue or cytologic sample available for the determination of EGFR
expression

- ECOG performance status 0-1

- Life expectancy >12 weeks

- Adequate baseline organ functions, defined as follows: *Serum creatinine ≤1.5 × upper
limit of normal (ULN). In case of borderline values for serum creatinine, creatinine
clearance must be ≥45 mL/min; *Total bilirubin <1.5 × ULN; *Alanine aminotransferase
(ALT)/aspartate aminotransferase (AST) ≤2.5 × ULN (Subjects with liver metastases
should have ALT/AST <5 × ULN.); *Absolute neutrophil count ≥1500/mm3; *Platelet count
≥100,000/mm3; *Hemoglobin level ≥10 g/dL11

- If procreative potential (male or female), willingness to use effective contraceptive
methods for the duration of treatment and continuing for 2 months after the last
dose. Subjects of procreative potential are defined as any fertile male, or any
female who has experienced menarche and who is not postmenopausal (defined as
age-related amenorrhea ≥12 months) or who has not undergone successful surgical
sterilization (hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

- Radiotherapy or major surgery within 30 days prior to the start of study treatment

- Prior treatment with an EGFR-directed therapy or with EGFR signal transduction
inhibitors

- Prior treatment with pemetrexed

- Pregnant (confirmed by β-HCG) or lactating female

- Weight loss >10% within 12 weeks prior to the start of study treatment

- Documented or symptomatic brain metastases or leptomeningeal disease

- Myocardial infarction within 6 months prior to the start of study treatment,
uncontrolled congestive heart failure, or any current New York Heart Association
Grade III or IV cardiovascular disorder despite treatment

- Presence of a ≥Grade 2 preexisting skin disorder (except for alopecia)

- Previous diagnosis of autoimmune disease with significant organ involvement

- Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years,
except for adequately treated basal cell carcinoma of the skin or in situ carcinoma
of the cervix

- Any significant disease that, in the Investigator's opinion, should exclude the
subject from the study

- History of significant neurologic or psychiatric disorder (e.g., dementia, seizures,
or bipolar disorder)

- History of drug abuse within 6 months prior to the start of study treatment

- Known conditions that require concurrent treatment with a nonpermitted drug

- Presence of a contraindication to the study treatment(s) according to the current
Investigator's Brochure (IB) for matuzumab and the labeling for pemetrexed

- Known hypersensitivity to the study treatment or any of its components

- Participation in another clinical study within 30 days prior to the start of study
treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Independent radiological response rate

Outcome Time Frame:

various timepoints measured

Safety Issue:

No

Principal Investigator

Joan Schiller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas

Authority:

United States: Food and Drug Administration

Study ID:

EMD 72000-031

NCT ID:

NCT00111839

Start Date:

August 2005

Completion Date:

March 2009

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Carcinoma
  • Lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202
Rush University Medical CenterChicago, Illinois  60612-3824
University of MissouriColumbia, Missouri  65212
Georgia Cancer SpecialistsDecatur, Georgia  30033
University of MinnesotaMinneapolis, Minnesota  55455
Sharp Memorial HospitalSan Diego, California  92123
Arizona Clinical Research CenterTucson, Arizona  85712
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
University of North CarolinaChapel Hill, North Carolina  27599
Deaconess Billings ClinicBillings, Montana  59107-5100
Hematology-Oncology ClinicBaton Rouge, Louisiana  70808
Holy Cross HospitalFort Lauderdale, Florida  33308
Henry Ford Health SystemsDetroit, Michigan  48202
Providence Portland Medical CenterPortland, Oregon  97213-3635
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The Cleveland Clinic FoundationCleveland, Ohio  
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Louisville OncologyLouisville, Kentucky  40202
Frederick Memorial HospitalFrederick, Maryland  21701
West Michigan Regional Cancer and Blood CenterLudington, Michigan  49431
Peachtree Hematology and OncologyAtlanta, Georgia  40202
Hematology & Oncology Associates of NEPADunmore, Pennsylvania  18512
University of WisconsinMadison,, Wisconsin  53792-5666
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Indiana Oncology Hematology ConsultantsIndianapolis, Indiana  46202
Dayton Oncology and HematologyKettering, Ohio  
Kansas City Cancer CenterKansas City, Kansas  66112
University of Arkansas, Arkansas Cancer Research CenterLittle Rock, Arkansas  72205
University of Southern California/Norris Cancer CenterLos Angeles, California  90033
Cancer Center or FloridaOcoee, Florida  34761
University of IllinoisChicago, Illinois  60612
Cancer Care Specialists of Central IllinoisDecatur, Illinois  62256
Cancer Institute of Alexian BrothersElk Grove Village, Illinois  60007
Hematology-Oncology of Indiana PCIndianapolis, Indiana  46260
Tuffs-New England Medical CenterBoston, Massachusetts  20111
Nebraska Hematology-Oncology, PCLincoln, Nebraska  68506
New York OncologyAlbany, New York  12208
Presbyterian Hospital Cancer CenterCharlotte, North Carolina  28204
Mary Crowley Research CenterDallas, Texas  75246
Rainer Oncology Professional ServicesPuyallup, Washington  98372