Trial Outcomes & Findings for Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer (NCT NCT00485485)
NCT ID: NCT00485485
Last Updated: 2012-08-07
Results Overview
Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
COMPLETED
PHASE2
7 participants
At 6 weeks reconfirmed 6 weeks later
2012-08-07
Participant Flow
Overall Study Recruitment: 1/18/2007 - 3/18/2008. All recruitment done at UT MD Anderson Cancer Center.
Patient has received any other investigational agents within 30 days of first day of study drug dosing; Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
Participant milestones
| Measure |
Imatinib Mesylate + Docetaxel
Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate + Docetaxel
n=7 Participants
Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
62 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 weeks reconfirmed 6 weeks laterResponse rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
Outcome measures
| Measure |
Imatinib Mesylate + Docetaxel
n=7 Participants
Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
|
|---|---|
|
Participant Response Rate
|
7 Participants
|
Adverse Events
Imatinib Mesylate + Docetaxel
Serious adverse events
| Measure |
Imatinib Mesylate + Docetaxel
n=7 participants at risk
Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
|
|---|---|
|
Infections and infestations
Neutropenic Fever
|
14.3%
1/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Infections and infestations
PEG SITE INFECTION G3
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
ANEMIA G3
|
14.3%
1/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
Swelling G3
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Renal and urinary disorders
Sepsis
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
Thrombocytopenia (Grade 3)
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Gastrointestinal disorders
Mucositis G3
|
14.3%
1/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Gastrointestinal disorders
Dysphagia G3
|
14.3%
1/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
General disorders
Cardiovascular Pain
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
Other adverse events
| Measure |
Imatinib Mesylate + Docetaxel
n=7 participants at risk
Imatinib 400 mg orally daily; Docetaxel 60 mg/m\^2 by vein over 1 hour every 3 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
71.4%
5/7 • Number of events 5 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (Other)
|
28.6%
2/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
28.6%
2/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Metabolism and nutrition disorders
Bilirubin
|
28.6%
2/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 2 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
|
Blood and lymphatic system disorders
Neutrophils (ANC/AGC)
|
42.9%
3/7 • Number of events 3 • Study Period of 3 years, one month (1/18/2007 - 2/24/2010)
|
Additional Information
Anne Tsao, M.D. / Associate Professor
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place