Trial Outcomes & Findings for Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer (NCT NCT00161213)

Last Updated: 2023-08-14

Results Overview

Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

4 years

Results posted on

2023-08-14

Participant Flow

The recruitment period spanned from October 2005 through July 2009. The trial was opened at a single regional cancer center and then expanded to other centers to reach accrual goals within the target period. These included hospitals in the CINJ Oncology Group and Northwestern University's Robert H. Lurie Comprehensive Cancer Center.

Participant milestones

Participant milestones
Measure	Gemcitabine and Imatinib imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Overall Study STARTED	44
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine and Imatinib imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Overall Study Withdrawal by Subject	1
Overall Study Evaluable for toxicity but not response	1

Baseline Characteristics

Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine and Imatinib n=44 Participants imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Outcome measures
Measure	Gemcitabine and Imatinib n=42 Participants imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Progression-free Survival	3.9 months Interval 2.06 to 5.14

SECONDARY outcome

Timeframe: 5 years

Population: A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.

Response rate as defined by a best response of "Stable Disease or better."

Outcome measures

Outcome measures
Measure	Gemcitabine and Imatinib n=35 Participants imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Response Rate	48.6 percentage of total evaluable subjects Interval 33.0 to 64.4

SECONDARY outcome

Timeframe: 5 years

Percentage of subjects who survive up to 1 year

Outcome measures

Outcome measures
Measure	Gemcitabine and Imatinib n=42 Participants imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
1-year Survival Rate	25.6 percentage of total evaluable subjects Interval 13.8 to 39.1

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Gemcitabine and Imatinib n=42 Participants imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Overall Survival	6.23 months Interval 5.15 to 8.46

Adverse Events

Gemcitabine and Imatinib

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine and Imatinib n=43 participants at risk imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	4.7% 2/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Pain - Abdomen not otherwise specified	4.7% 2/43 • Number of events 2 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Vascular disorders Thrombosis/thrombus/embolism - pulmonary embolus	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Psychiatric disorders Mood alteration - Depression - pre-existing condition	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Biliary tree	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Vascular disorders Hemorrhage, GI - Lower GI NOS	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Nausea	4.7% 2/43 • Number of events 2 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Psychiatric disorders Psychosis (hallucinations/delusions)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Stricture/stenosis (including anastomotic), GI - Biliary tree	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Dehydration	2.3% 1/43 • Number of events 1 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.

Other adverse events

Other adverse events
Measure	Gemcitabine and Imatinib n=43 participants at risk imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days. gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days.
Gastrointestinal disorders Nausea	51.2% 22/43 • Number of events 97 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Constipation	27.9% 12/43 • Number of events 15 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Anorexia	25.6% 11/43 • Number of events 11 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Diarrhea	20.9% 9/43 • Number of events 9 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Vomiting	20.9% 9/43 • Number of events 9 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Gastrointestinal disorders Dehydration	9.3% 4/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	58.1% 25/43 • Number of events 66 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Leukocytes (total WBC)	46.5% 20/43 • Number of events 42 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Hemoglobin	39.5% 17/43 • Number of events 31 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Platelets	27.9% 12/43 • Number of events 30 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Blood/Bone Marrow - Other (Specify, __)	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Fatigue (asthenia, lethargy, malaise)	44.2% 19/43 • Number of events 27 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	20.9% 9/43 • Number of events 11 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Weight loss	11.6% 5/43 • Number of events 5 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders Alkaline phosphatase	14.0% 6/43 • Number of events 7 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	9.3% 4/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	9.3% 4/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Pain - Abdomen NOS	25.6% 11/43 • Number of events 18 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Pain - Back	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
General disorders Pain - Other (Specify, __)	7.0% 3/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Skin and subcutaneous tissue disorders Rash/desquamation	14.0% 6/43 • Number of events 6 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Nervous system disorders Memory impairment	9.3% 4/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Nervous system disorders Confusion	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Psychiatric disorders Mood alteration - Depression	7.0% 3/43 • Number of events 3 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Blood and lymphatic system disorders Edema: limb	18.6% 8/43 • Number of events 9 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Vascular disorders Thrombosis/thrombus/embolism	11.6% 5/43 • Number of events 8 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	9.3% 4/43 • Number of events 4 • 5 years All patients who received one dose of protocol therapy were evaluated for toxicity.

Additional Information

Dr. Susan Goodin (Deputy Director, Associate Director for Clinical Science)

UMDNJ

Phone: 732-235-6783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place