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A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Non-Small Cell Lung Cancer

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Trial Information

A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer


A phase II, randomized, controlled, double blinded and multicenter study with 2 arms,
administering the study drug during radiotherapy and following radiotherapy until disease
progression, unacceptable toxicity or at the discretion of the physician. Randomization will
be done 2:1 (experimental:control). Chemotherapy can be added before documented disease
progression at the discretion of the physician.

The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The
primary endpoint is intracranial disease progression over 6 months.

The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or
death with evidence of neurologic progression; OS rate at 6 months; time to intracranial
disease progression; and time to overall progression.

Tissue samples and serum will be collected for future correlative studies.

All the images will be centrally reviewed at the end of study.


Inclusion Criteria:



- Providing a written informed consent (see Appendix A);

- Age ≥18 years;

- Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type
(squamous, adenocarcinoma, large cell, or other);

- At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;

- Patient had initial diagnosis of brain metastases by image, within 8 weeks of
registration

- KPS ≥70;

- Absolute neutrophil count ≥ 1500/mm³;

- Platelet count ≥ 50,000/mm³;

- Serum creatinine ≤2.0 mg/dL;

- Serum transaminases ≤2 x the upper limit of normal (ULN);

- Total serum bilirubin ≤2 x ULN;

- And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.

Exclusion Criteria:

- Pregnancy, lactation or parturition within the previous 30 days (fertile female or
male patients should practice contraception);

- Prior WBRT, brain metastases resection with no other measurable lesion remaining;

- Extracranial metastases in two or more organs;

- Known leptomeningeal or subarachnoid tumor spread;

- Plan to use radiosurgery or radiation boost after completion of WBRT;

- Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;

- Previous use of an anti-EGFR drug;

- Participation in another ongoing therapeutic trial;

- Presence of known HIV seropositivity, severe comorbidities, or other malignant
neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma
of skin or in situ carcinoma of the uterine cervix);

- Hypersensitivity or allergy to any of the drugs to be administered in this study;

- Inability or unwillingness to complete the required assessments;

- Geographic inaccessibility for treatment or follow-up evaluations.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination

Outcome Time Frame:

weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.

Safety Issue:

Yes

Principal Investigator

Anthony Brade, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assitant Professor, Department of Radiation Oncology, University of Toronto

Authority:

Canada: Health Canada

Study ID:

YMB1000-018

NCT ID:

NCT00872482

Start Date:

April 2009

Completion Date:

July 2011

Related Keywords:

  • Metastatic Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • NSCLC
  • Brain metastases
  • nimotuzumab
  • TheraCIM
  • h-R3
  • Radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms

Name

Location

Overlake Hospital Medical CenterBellevue, Washington  98004
Florida Cancer Institute - New HopeNew Port Richey, Florida  34655
Park Nicollet Institute - Frauenshuh Cancer CenterSt. Louis Park, Minnesota  55426