Trial Outcomes & Findings for Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy (NCT NCT00694603)
NCT ID: NCT00694603
Last Updated: 2012-09-06
Results Overview
TERMINATED
PHASE2
56 participants
8 weeks
2012-09-06
Participant Flow
We recruited patients to this multicenter, single-arm, phase II clinical trial with ECOG PS 0 to 2 and advanced NSCLC who were previously treated with erlotinib or gefitinib. Patients with asymptomatic, stable CNS metastases were eligible. 18 eligible patients were enrolled in the first stage of the trial between October 2006 and March 2009.
All patients were required to have an available tissue sample for EGFR mutation testing, which was performed centrally at a CLIA-certified laboratory.
Participant milestones
| Measure |
Cetuximab
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy
Baseline characteristics by cohort
| Measure |
Cetuximab
n=18 Participants
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was \<3%. PFSand OS were calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Cetuximab
n=18 Participants
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Response Rate by CT Scan Using RECIST Criteria
|
0 participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 monthsOutcome measures
| Measure |
Cetuximab
n=18 Participants
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Progression-free Survival
|
1.8 months
Interval 1.6 to 5.4
|
Adverse Events
Cetuximab
Serious adverse events
| Measure |
Cetuximab
n=18 participants at risk
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
interstitial lung disease
|
5.6%
1/18
|
|
Nervous system disorders
headache
|
5.6%
1/18
|
|
Cardiac disorders
chest pain
|
5.6%
1/18
|
|
Reproductive system and breast disorders
wheezing
|
5.6%
1/18
|
Other adverse events
| Measure |
Cetuximab
n=18 participants at risk
Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
44.4%
8/18
|
|
Gastrointestinal disorders
nausea
|
16.7%
3/18
|
|
General disorders
fatigue
|
22.2%
4/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place