Trial Outcomes & Findings for Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer (NCT NCT00231465)
NCT ID: NCT00231465
Last Updated: 2017-03-03
Results Overview
ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (\> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): \* Complete Response (CR)- Disappearance of all target lesions; \* Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; \* Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the 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.
COMPLETED
PHASE2
44 participants
Duration of time on study, an average of 19 months
2017-03-03
Participant Flow
Participant milestones
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
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|---|---|
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Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
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|---|---|
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Overall Study
Completed only one cycle
|
1
|
|
Overall Study
Did not have follow up CT scans
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1
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Baseline Characteristics
Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=44 Participants
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Age, Customized
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75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of time on study, an average of 19 monthsPopulation: Response was evaluable in 42 of the 44 patients.
ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (\> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): \* Complete Response (CR)- Disappearance of all target lesions; \* Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; \* Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the 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
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=42 Participants
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Overall Response Rate (ORR)
|
40 percentage of participants
Interval 26.0 to 57.0
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SECONDARY outcome
Timeframe: Duration of time on study, an average of 19 monthsPopulation: All participants who initiated therapy between March 2003 and May 2005
PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=44 Participants
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Progression Free Survival (PFS) Rate
|
6.9 Months
Interval 3.95 to 7.8
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SECONDARY outcome
Timeframe: Duration of time on study, an average of 19 monthsPopulation: All participants who initiated therapy between March 2003 and May 2005
OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.
Outcome measures
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=44 Participants
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Overall Survival (OS) Rate
|
9.59 Months
Interval 4.6 to 16.3
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Adverse Events
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
Serious adverse events
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=44 participants at risk
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Infections and infestations
Neutropenia
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.2%
8/44 • Number of events 8 • 7 years, 2 months
|
|
Infections and infestations
Febrile neutropenia
|
9.1%
4/44 • Number of events 4 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.4%
5/44 • Number of events 5 • 7 years, 2 months
|
|
General disorders
Fatigue
|
9.1%
4/44 • Number of events 4 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Elevated SGPT
|
4.5%
2/44 • Number of events 2 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates
|
4.5%
2/44 • Number of events 2 • 7 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.5%
2/44 • Number of events 2 • 7 years, 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Gastrointestinal disorders
Dysphagia/Esophagitis
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia (neutropenic)
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of COPD
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Elevated creatinine
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Renal and urinary disorders
Interstitial cystitis
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
General disorders
Syncope
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Vascular disorders
Stroke
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Infections and infestations
Herpes zoster
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
|
Gastrointestinal disorders
Dehydration
|
2.3%
1/44 • Number of events 1 • 7 years, 2 months
|
Other adverse events
| Measure |
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
n=44 participants at risk
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.
docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
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|---|---|
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Infections and infestations
Neutropenia
|
9.1%
4/44 • Number of events 4 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
4/44 • Number of events 4 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
72.7%
32/44 • Number of events 43 • 7 years, 2 months
|
|
General disorders
Fatigue
|
79.5%
35/44 • Number of events 60 • 7 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.5%
24/44 • Number of events 35 • 7 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
11/44 • Number of events 11 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.6%
6/44 • Number of events 20 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.1%
15/44 • Number of events 18 • 7 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
15.9%
7/44 • Number of events 7 • 7 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.1%
15/44 • Number of events 23 • 7 years, 2 months
|
|
Nervous system disorders
Neuropathy - Sensory
|
9.1%
4/44 • Number of events 4 • 7 years, 2 months
|
|
General disorders
Bone pain
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Edema
|
9.1%
4/44 • Number of events 5 • 7 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Gastrointestinal disorders
Nausea
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Alkaline phosphatase
|
20.5%
9/44 • Number of events 22 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
29.5%
13/44 • Number of events 15 • 7 years, 2 months
|
|
General disorders
Fever
|
4.5%
2/44 • Number of events 2 • 7 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Allergic rhinitis
|
4.5%
2/44 • Number of events 3 • 7 years, 2 months
|
|
General disorders
Bone Pain
|
11.4%
5/44 • Number of events 5 • 7 years, 2 months
|
|
Gastrointestinal disorders
Constipation
|
11.4%
5/44 • Number of events 7 • 7 years, 2 months
|
|
Renal and urinary disorders
Creatinine
|
18.2%
8/44 • Number of events 29 • 7 years, 2 months
|
|
Gastrointestinal disorders
Diarrhea w/o colostomy
|
22.7%
10/44 • Number of events 17 • 7 years, 2 months
|
|
General disorders
Dizziness
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
47.7%
21/44 • Number of events 35 • 7 years, 2 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
2/44 • Number of events 3 • 7 years, 2 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
3/44 • Number of events 3 • 7 years, 2 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
56.8%
25/44 • Number of events 89 • 7 years, 2 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.5%
2/44 • Number of events 2 • 7 years, 2 months
|
|
Gastrointestinal disorders
Stomatitis
|
11.4%
5/44 • Number of events 5 • 7 years, 2 months
|
Additional Information
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place