Trial Outcomes & Findings for Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery (NCT NCT00991952)
NCT ID: NCT00991952
Last Updated: 2014-05-26
Results Overview
Response was determined as indicated in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From the start of treatment for up to 3 months
Results posted on
2014-05-26
Participant Flow
Protocol Open to Accrual 09/09/2009 Protocol Closed to Accrual 02/28/2012 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Irinotecan Hydrochloride and Alvocidib
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
13
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Irinotecan Hydrochloride and Alvocidib
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Irinotecan Hydrochloride and Alvocidib
n=13 Participants
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
n=6 Participants
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 19.0918830 • n=5 Participants
|
56 years
STANDARD_DEVIATION 16.97056275 • n=7 Participants
|
60 years
STANDARD_DEVIATION 22.627417 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment for up to 3 monthsResponse was determined as indicated in the protocol.
Outcome measures
| Measure |
Irinotecan Hydrochloride and Alvocidib
n=13 Participants
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
n=5 Participants
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
|---|---|---|
|
Overall Response Rate
Partial Response
|
1 participants
|
0 participants
|
|
Overall Response Rate
Stable Disease
|
4 participants
|
1 participants
|
|
Overall Response Rate
Progression of Disease
|
8 participants
|
4 participants
|
Adverse Events
Irinotecan Hydrochloride and Alvocidib
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Irinotecan Hydrochloride
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irinotecan Hydrochloride and Alvocidib
n=13 participants at risk
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
n=6 participants at risk
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Death-Disease Progression NOS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Neutrophil count decrease
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Death NOS
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Edema limbs
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Investigations
INR increased
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, gastric
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Irinotecan Hydrochloride and Alvocidib
n=13 participants at risk
Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
|
Irinotecan Hydrochloride
n=6 participants at risk
Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
23.1%
3/13 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
30.8%
4/13 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
69.2%
9/13 • Number of events 9
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
5/13 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
|
Investigations
Aspartate aminotransferase
|
30.8%
4/13 • Number of events 4
|
0.00%
0/6
|
|
Investigations
Blood bilirubin increased
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Creatinine increased
|
23.1%
3/13 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
5/13 • Number of events 5
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fatigue
|
69.2%
9/13 • Number of events 9
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
61.5%
8/13 • Number of events 8
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
53.8%
7/13 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
69.2%
9/13 • Number of events 9
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.8%
4/13 • Number of events 4
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.1%
3/13 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.1%
3/13 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Investigations
INR increased
|
15.4%
2/13 • Number of events 2
|
0.00%
0/6
|
|
Investigations
Lymphocyte count decreased
|
38.5%
5/13 • Number of events 5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
46.2%
6/13 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.1%
3/13 • Number of events 3
|
0.00%
0/6
|
|
Investigations
Platelet count decreased
|
15.4%
2/13 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Investigations
White blood cell decreased
|
76.9%
10/13 • Number of events 10
|
50.0%
3/6 • Number of events 3
|
Additional Information
Dr. Yelena Janjigian
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60