Phase 3
N=472
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Lung Cancer, Non-Small Cell
Bottom Line
View on ClinicalTrials.gov: NCT00390806 ↗Enrolled (actual)
472
Serious AEs
29.7%
Results posted
Jan 2014
Primary outcome: Primary: Overall Survival — 4.0; 3.6 months — p=0.1862
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HYCAMTIN, oral capsules (Drug); Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
4.0; 3.6 | 0.1862 |
| SECONDARY Six-month Survival |
36; 28 | — |
| SECONDARY Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic) |
23; 11; 63; 61 | — |
| SECONDARY Time to Response (TTR) (CNS-radiologic) |
8.0; 8.1 | — |
| SECONDARY Time to Progression (TTP) (CNS-radiologic) |
9.7; 9.7 | — |
| SECONDARY Time to Progression (TTP) (All Sites of Disease-radiologic) |
8.0; 7.7 | — |
| SECONDARY Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3 |
93; 106; 71; 68; 11; 13 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3 |
219; 216; 171; 169; 102; 92 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3 |
141; 146; 126; 127; 85; 74 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3 |
160; 151; 124; 128; 76; 76 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3 |
180; 173; 148; 150; 90; 86 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3 |
203; 192; 151; 162; 88; 93 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3 |
181; 189; 148; 154; 93; 93 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3 |
218; 216; 175; 178; 109; 101 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3 |
219; 214; 165; 171; 99; 101 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3 |
218; 211; 172; 169; 106; 102 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3 |
211; 215; 169; 173; 105; 98 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3 |
203; 195; 153; 159; 93; 89 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3 |
197; 202; 149; 157; 90; 86 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3 |
196; 189; 137; 145; 81; 80 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3 |
182; 190; 128; 143; 76; 73 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3 |
197; 192; 144; 159; 100; 94 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 |
206; 198; 166; 166; 103; 95 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3 |
199; 201; 156; 162; 97; 94 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3 |
172; 178; 138; 147; 85; 76 | — |
| SECONDARY Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3 |
153; 152; 131; 128; 78; 75 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE) |
204; 148; 96; 43 | — |
| SECONDARY Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range |
32; 21; 116; 144; 22; 6 | — |
| SECONDARY Lesion Assessment and Measurement |
— | — |
| SECONDARY Brain Symptoms |
— | — |
| SECONDARY Number of Participants Who Died or Progressed |
179; 161 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00390806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.