Trial Outcomes & Findings for Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer (NCT NCT01185171)
NCT ID: NCT01185171
Last Updated: 2023-05-11
Results Overview
To explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
1 month
Results posted on
2023-05-11
Participant Flow
From February 2003 to October 2004, 70 patients signed consent at three participating institutions.
1 patient withdrew before initiating therapy and was not included in the trial. 10 patients underwent surgery to remove all gross disease before initiating study and were unevaluable for response.
Participant milestones
| Measure |
ZD1839 500mg by Mouth (po) Daily
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Induction Chemotherapy
STARTED
|
59
|
|
Induction Chemotherapy
COMPLETED
|
57
|
|
Induction Chemotherapy
NOT COMPLETED
|
2
|
|
Concurrent Chemo and Radiation Treatment
STARTED
|
69
|
|
Concurrent Chemo and Radiation Treatment
COMPLETED
|
66
|
|
Concurrent Chemo and Radiation Treatment
NOT COMPLETED
|
3
|
|
Maintenance
STARTED
|
60
|
|
Maintenance
COMPLETED
|
48
|
|
Maintenance
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
ZD1839 500mg by Mouth (po) Daily
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Induction Chemotherapy
Withdrawal by Subject
|
1
|
|
Induction Chemotherapy
Duodenal Ulcer
|
1
|
|
Concurrent Chemo and Radiation Treatment
Death
|
3
|
|
Maintenance
Elevated liver transaminases
|
3
|
|
Maintenance
Rush
|
2
|
|
Maintenance
Diarrhea
|
1
|
|
Maintenance
Xerostomia
|
1
|
|
Maintenance
Nausea
|
1
|
|
Maintenance
Comorbid Illness
|
2
|
|
Maintenance
Withdrawal by Subject
|
1
|
|
Maintenance
Disease Recurrence
|
1
|
Baseline Characteristics
Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer
Baseline characteristics by cohort
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 Participants
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthTo explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
Outcome measures
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=59 Participants
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Complete Response Rate Achieved 1 Month After Concurrent Chemotherapy and Radiation Treatment
|
52 Participants
|
SECONDARY outcome
Timeframe: 0.3 to 4.7 yearsPercentage of patients who survived 4 years or more
Outcome measures
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 Participants
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
4 Year Overall Survival
|
74 percentage of patients
Interval 62.0 to 83.0
|
SECONDARY outcome
Timeframe: 0.3 to 4.7 yearsPercentage of patients who survived without progressive disease 4 years or more
Outcome measures
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 Participants
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
4 Year Progression Free Survival
|
72 percentage of patients
Interval 60.0 to 81.0
|
SECONDARY outcome
Timeframe: 0.3 to 4.7 yearsPercentage of patients who did not die by the disease within 4 years
Outcome measures
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 Participants
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
4 Year Disease Specific Survival
|
89 percentage of patients
Interval 77.0 to 95.0
|
Adverse Events
ZD1839 500mg by Mouth (po) Daily
Serious events: 17 serious events
Other events: 69 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 participants at risk
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Mucositis
|
10.1%
7/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Anorexia
|
1.4%
1/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Pain
|
1.4%
1/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.6%
8/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.3%
3/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Sudden Death
|
1.4%
1/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Cardiac disorders
Death NOS
|
1.4%
1/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Infection
|
4.3%
3/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
2/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
Other adverse events
| Measure |
ZD1839 500mg by Mouth (po) Daily
n=69 participants at risk
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
75.4%
52/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Vomiting
|
53.6%
37/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Mucositis
|
92.8%
64/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Constipation
|
11.6%
8/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Fatigue
|
91.3%
63/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Diarrhea
|
42.0%
29/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Fever
|
21.7%
15/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Gastrointestinal disorders
Anorexia
|
59.4%
41/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Alopecia
|
69.6%
48/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Pain
|
88.4%
61/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
89.9%
62/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Nervous system disorders
Neurotoxicity
|
37.7%
26/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
General disorders
Infection
|
11.6%
8/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
89.9%
62/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.9%
31/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Skin and subcutaneous tissue disorders
EGFR related rash
|
46.4%
32/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia
|
13.0%
9/69 • The adverse events were collected during the IC and CCRT periods (3 months).
|
Additional Information
Dr Everett Vokes, MD
University of Chicago Medicine and Biological Sciences
Phone: 855-702-8222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place