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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 Center Louisville, Kentucky  40202
Rush University Medical Center Chicago, Illinois  60612-3824
University of Missouri Columbia, Missouri  65212
Georgia Cancer Specialists Decatur, Georgia  30033
University of Minnesota Minneapolis, Minnesota  55455
Sharp Memorial Hospital San Diego, California  92123
Arizona Clinical Research Center Tucson, Arizona  85712
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
University of North Carolina Chapel Hill, North Carolina  27599
Deaconess Billings Clinic Billings, Montana  59107-5100
Hematology-Oncology Clinic Baton Rouge, Louisiana  70808
Holy Cross Hospital Fort Lauderdale, Florida  33308
Henry Ford Health Systems Detroit, Michigan  48202
Providence Portland Medical Center Portland, Oregon  97213-3635
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
The Cleveland Clinic Foundation Cleveland, Ohio  
Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131
Louisville Oncology Louisville, Kentucky  40202
Frederick Memorial Hospital Frederick, Maryland  21701
West Michigan Regional Cancer and Blood Center Ludington, Michigan  49431
Peachtree Hematology and Oncology Atlanta, Georgia  40202
Hematology & Oncology Associates of NEPA Dunmore, Pennsylvania  18512
University of Wisconsin Madison,, Wisconsin  53792-5666
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Indiana Oncology Hematology Consultants Indianapolis, Indiana  46202
Dayton Oncology and Hematology Kettering, Ohio  
Kansas City Cancer Center Kansas City, Kansas  66112
University of Arkansas, Arkansas Cancer Research Center Little Rock, Arkansas  72205
University of Southern California/Norris Cancer Center Los Angeles, California  90033
Cancer Center or Florida Ocoee, Florida  34761
University of Illinois Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Cancer Institute of Alexian Brothers Elk Grove Village, Illinois  60007
Hematology-Oncology of Indiana PC Indianapolis, Indiana  46260
Tuffs-New England Medical Center Boston, Massachusetts  20111
Nebraska Hematology-Oncology, PC Lincoln, Nebraska  68506
New York Oncology Albany, New York  12208
Presbyterian Hospital Cancer Center Charlotte, North Carolina  28204
Mary Crowley Research Center Dallas, Texas  75246
Rainer Oncology Professional Services Puyallup, Washington  98372