Trial Outcomes & Findings for Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer (NCT NCT00268346)
NCT ID: NCT00268346
Last Updated: 2016-01-05
Results Overview
The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
at 8 weeks after initiation of treatment
Results posted on
2016-01-05
Participant Flow
Subjects recruited from April 2003 to January 2010 from medical clinic
Participant milestones
| Measure |
No Prior Chem Therapy
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Prior Chemotherapy
Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
40
|
|
Overall Study
Started Treatment
|
18
|
40
|
|
Overall Study
COMPLETED
|
18
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
No Prior Chem Therapy
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Prior Chemotherapy
Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
No Prior Chem Therapy
n=18 Participants
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Prior Chemotherapy
n=40 Participants
Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
58 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 8 weeks after initiation of treatmentPopulation: All patients enrolled were analyzed
The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.
Outcome measures
| Measure |
No Prior Therapy
n=18 Participants
All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
|
Prior Chemotherapy
n=40 Participants
All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
|
|---|---|---|
|
The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.
|
1 participants
Interval 0.1 to 27.3
|
3 participants
Interval 1.6 to 20.4
|
Adverse Events
No Prior Chem Therapy
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Prior Chemotherapy
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Prior Chem Therapy
n=18 participants at risk
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Prior Chemotherapy
n=40 participants at risk
Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
General disorders
death
|
0.00%
0/18 • From study start to 30 days after final treatment
|
2.5%
1/40 • Number of events 1 • From study start to 30 days after final treatment
|
|
General disorders
hospitalization
|
22.2%
4/18 • Number of events 4 • From study start to 30 days after final treatment
|
7.5%
3/40 • Number of events 3 • From study start to 30 days after final treatment
|
Other adverse events
| Measure |
No Prior Chem Therapy
n=18 participants at risk
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
Prior Chemotherapy
n=40 participants at risk
Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Anorexia
|
11.1%
2/18 • From study start to 30 days after final treatment
|
7.5%
3/40 • From study start to 30 days after final treatment
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18 • From study start to 30 days after final treatment
|
50.0%
20/40 • From study start to 30 days after final treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/18 • From study start to 30 days after final treatment
|
5.0%
2/40 • From study start to 30 days after final treatment
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
3/18 • From study start to 30 days after final treatment
|
10.0%
4/40 • From study start to 30 days after final treatment
|
|
General disorders
Fatigue
|
0.00%
0/18 • From study start to 30 days after final treatment
|
5.0%
2/40 • From study start to 30 days after final treatment
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
0.00%
0/18 • From study start to 30 days after final treatment
|
5.0%
2/40 • From study start to 30 days after final treatment
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • From study start to 30 days after final treatment
|
10.0%
4/40 • From study start to 30 days after final treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.4%
8/18 • From study start to 30 days after final treatment
|
77.5%
31/40 • From study start to 30 days after final treatment
|
Additional Information
David Adelstein MD
Cleveland Clinic Taussig Cancer Institute
Phone: 216-444-9310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place