Trial Outcomes & Findings for Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery (NCT NCT00539617)
NCT ID: NCT00539617
Last Updated: 2020-03-23
Results Overview
PFS is defined as the duration of time from enrollment into the run-in period of the study to objective tumor progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The proportion of patients with PFS will be reported and evaluated using Kaplan-Meier survival curves with median survival and 95% confidence interval.
TERMINATED
PHASE2
7 participants
Up to 2 years
2020-03-23
Participant Flow
Recruitment is performed in the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco
This trial has a pre-enrollment phase in which patients have their tissue tested for Kras and EGFR mutations to determine eligibility for the treatment trial. There is also a run-in phase with Erlotinib followed by a post-treatment biopsy. After this, the main treatment phase begins.
Participant milestones
| Measure |
FOLFOX and Erlotinib
Single arm study of FOLFOX6 plus Erlotinib
|
|---|---|
|
Pre-screening Period
STARTED
|
7
|
|
Pre-screening Period
COMPLETED
|
4
|
|
Pre-screening Period
NOT COMPLETED
|
3
|
|
Run-In Period
STARTED
|
4
|
|
Run-In Period
COMPLETED
|
3
|
|
Run-In Period
NOT COMPLETED
|
1
|
|
Treatment Period
STARTED
|
3
|
|
Treatment Period
COMPLETED
|
3
|
|
Treatment Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
FOLFOX and Erlotinib
n=7 Participants
Single arm study of FOLFOX6 plus Erlotinib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: No data was collected for progression free survival
PFS is defined as the duration of time from enrollment into the run-in period of the study to objective tumor progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The proportion of patients with PFS will be reported and evaluated using Kaplan-Meier survival curves with median survival and 95% confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No data was collected for overall response rate
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). Best response assignment will depend on the achievement of both measurement and confirmation criteria using RECIST for both target and non-target lesions. For target lesions, response is defined as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in sum of the LD, taking as reference the baseline sum LD; PD: \>=20% increase in sum of the LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions , Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No data was collected for time to progression
Patient with objective tumor response or stable disease will be treated with single agent Tarceva until tumor progression. For this study, time to progression will be determined as the number of days following the first day of single agent treatment with Tarceva following the last and completed cycle of Tarcerva/FOLFOX combination therapy. TTP will be calculated for the entire patient population as well as for patients that objectively responded to the combination therapy versus those that did not.
Outcome measures
Outcome data not reported
Adverse Events
FOLFOX and Erlotinib
Serious adverse events
| Measure |
FOLFOX and Erlotinib
n=4 participants at risk
Single arm study of FOLFOX6 plus Erlotinib
|
|---|---|
|
Gastrointestinal disorders
Dehydration
|
50.0%
2/4 • Number of events 2 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Cardiac disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
Other adverse events
| Measure |
FOLFOX and Erlotinib
n=4 participants at risk
Single arm study of FOLFOX6 plus Erlotinib
|
|---|---|
|
Gastrointestinal disorders
Abdomimal distention
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
2/4 • Number of events 2 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
75.0%
3/4 • Number of events 7 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
2/4 • Number of events 2 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
General disorders
Confusion
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 5 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
2/4 • Number of events 2 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Blood and lymphatic system disorders
Edema, limbs
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 6 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Endocrine disorders
Hypothroidism
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Blood and lymphatic system disorders
Neutrophil
|
75.0%
3/4 • Number of events 3 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Oral Pain
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
General disorders
Pain, other
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
75.0%
3/4 • Number of events 4 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Taste Alteration
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Renal and urinary disorders
Urogenital disorder
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • Number of events 3 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
General disorders
Weight loss
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
|
Gastrointestinal disorders
Tongue Ulcer
|
25.0%
1/4 • Number of events 1 • Up to 2 years
Adverse events were collected from first dose to 30 days after last dose for the 4 patients who started treatment.
|
Additional Information
W. Michael Korn, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place