Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer, Non-Small Cell

Treatments: Drug: HYCAMTIN, oral capsules; Radiation: Radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390806

HYT105962

Details and patient eligibility

About

The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.

Enrollment: 472 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
• Must have received previous chemotherapy
• Must be 18 years of age of greater
• Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
• At least 2 weeks must have elapsed since any surgery
• At least 4 weeks must have elapsed since any radiation to a non-CNS site
• Must have adequate bone marrow, renal, and live capacities
• Women must be of non-childbearing potential or practice adequate birth control
• Males must practice adequate methods of birth control
• Must sign written informed consent

Exclusion criteria

• Previous whole brain radiation therapy
• Prior treatment with topotecan
• Investigational agent within 30 days or 5 half-live
• Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
• Primary or secondary immunodeficiencies
• Gastrointestinal conditions that affect GI absorption or motility
• Uncontrolled emesis
• Brain metastasis at time of initial diagnosis of NSCLC
• History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
• Pregnant or intending to become pregnant or intending to father a baby
• Any severe concurrent medical condition that could affect compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

topotecan plus radiation

Experimental group

Description:

topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.

Treatment:

Radiation: Radiation

Drug: HYCAMTIN, oral capsules

Whole brain radiation

Active Comparator group

Description:

Whole brain radiation 3 Gy/day for 10 days

Treatment:

Radiation: Radiation