Trial Outcomes & Findings for Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer (NCT NCT00248560)
NCT ID: NCT00248560
Last Updated: 2019-03-05
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
every 8 weeks for approximately 8 - 48 weeks
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Docetaxel
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Docetaxel
n=36 Participants
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 8 weeks for approximately 8 - 48 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gemcitabine, Docetaxel
n=36 Participants
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Response (Complete Response [CR] + Partial Response [PR])
|
6 participants
|
SECONDARY outcome
Timeframe: Every 8 weeksPopulation: Only those patients that have a recorded CR or PR
Response duration in months
Outcome measures
| Measure |
Gemcitabine, Docetaxel
n=6 Participants
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Response Duration
|
3.2 months
Interval 2.0 to 6.1
|
SECONDARY outcome
Timeframe: Every 8 weeksOverall Survival using the Kaplan-Meier method
Outcome measures
| Measure |
Gemcitabine, Docetaxel
n=36 Participants
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Survival
|
4.2 months
Interval 2.4 to 7.0
|
SECONDARY outcome
Timeframe: Every 2 weeksToxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
Outcome measures
| Measure |
Gemcitabine, Docetaxel
n=36 Participants
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Toxicity as Measured by Number and Grade of Adverse Events
Anemia
|
13 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Neutropenia
|
10 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Hyponatremia
|
10 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Dehydration
|
3 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Fatigue
|
3 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Dyspnea
|
3 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Pneumonia
|
3 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Thrombocytopenia
|
2 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Febrile neutropenia
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Tachycardia
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Syncope
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Fluid retention
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Mucositis
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Hyperglycemia
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Constipation
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Anorexia
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Vomiting
|
1 participants
|
|
Toxicity as Measured by Number and Grade of Adverse Events
Other non-hematologic toxicity
|
1 participants
|
Adverse Events
Gemcitabine, Docetaxel
Serious events: 25 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Docetaxel
n=36 participants at risk
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
36.1%
13/36 • Number of events 13
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.8%
10/36 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.8%
10/36 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Fatigue
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
3/36 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
3/36 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.8%
1/36 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
2.8%
1/36 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Fluid Retention
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
1/36 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine, Docetaxel
n=36 participants at risk
Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
52.8%
19/36 • Number of events 19
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
6/36 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
9/36 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
3/36 • Number of events 3
|
|
General disorders
Fatigue
|
22.2%
8/36 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
2/36 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.7%
15/36 • Number of events 15
|
|
Cardiac disorders
Tachycardia
|
11.1%
4/36 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Fluid Retention
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
5/36 • Number of events 5
|
|
Investigations
Creatinine
|
11.1%
4/36 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.4%
7/36 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
4/36 • Number of events 4
|
Additional Information
Ammar Sukari, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place