Trial Outcomes & Findings for Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery (NCT NCT00536874)

NCT ID: NCT00536874

Last Updated: 2017-03-16

Results Overview

Percentage of participants that were alive or survived at 18 months after randomization

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

18 months

Results posted on

2017-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine And Oxaliplatin A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine And Oxaliplatin A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Overall Study Adverse Event	1
Overall Study Death	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Gemcitabine and Oxaliplatin in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine And Oxaliplatin n=39 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Age, Continuous	63.5 years STANDARD_DEVIATION 33.23401872 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Percentage of participants that were alive or survived at 18 months after randomization

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Overall Survival at 18 Months	63 percentage of participants Interval 45.0 to 76.0

SECONDARY outcome

Timeframe: From Baseline until 2 Years and Follow-Up, up to 120 months

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Overall Survival (Follow-Up Time)	39.6 months Interval 12.3 to 57.7

SECONDARY outcome

Timeframe: Baseline and 2 years

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy CEA (Pre-Therapy)	4.2 ng/ml Interval 0.8 to 149.0
Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy CEA (Post-Therapy)	4.2 ng/ml Interval 0.8 to 82.0

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
RECIST Radiologic Response to Neoadjuvant Therapy Stable Disease	28 participants
RECIST Radiologic Response to Neoadjuvant Therapy Partial Response	4 participants
RECIST Radiologic Response to Neoadjuvant Therapy Progression of Disease	3 participants
RECIST Radiologic Response to Neoadjuvant Therapy Inevaluable	3 participants

SECONDARY outcome

Timeframe: Baseline and 2 years

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy Ca 19-9 (Pre-Therapy)	133 U/ml Interval 3.0 to 3816.0
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy Ca 19-9 (Post-Therapy)	132 U/ml Interval 5.0 to 2483.0

SECONDARY outcome

Timeframe: Baseline and 2 years

Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy	-5.1 percent change Interval -68.0 to 203.0

SECONDARY outcome

Timeframe: Baseline and 2 years

Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy

Outcome measures

Outcome measures
Measure	Gemcitabine And Oxaliplatin n=35 Participants A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy	-25.6 percent change Interval -85.0 to 289.0

Adverse Events

Gemcitabine And Oxaliplatin

Serious events: 25 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine And Oxaliplatin n=39 participants at risk A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Immune system disorders Allergic reaction-Hypersensitivity	2.6% 1/39 • Number of events 1
Metabolism and nutrition disorders Anorexia	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Ascites (non-malignant)	2.6% 1/39 • Number of events 1
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Number of events 1
Nervous system disorders Ischemia cerebrovascular	2.6% 1/39 • Number of events 1
Hepatobiliary disorders Cholecystitis	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Constipation	2.6% 1/39 • Number of events 1
General disorders General disorder	2.6% 1/39 • Number of events 1
General disorders Sudden death	5.1% 2/39 • Number of events 2
Metabolism and nutrition disorders Dehydration	5.1% 2/39 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/39 • Number of events 1
General disorders Fatigue	5.1% 2/39 • Number of events 2
General disorders Fever	15.4% 6/39 • Number of events 6
Gastrointestinal disorders Gastrointestinal disorder	2.6% 1/39 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	7.7% 3/39 • Number of events 3
Blood and lymphatic system disorders Anemia (Hemoglobin decrease)	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.6% 1/39 • Number of events 1
Vascular disorders Hypertension	2.6% 1/39 • Number of events 1
Infections and infestations Abdominal infection	2.6% 1/39 • Number of events 1
Infections and infestations Biliary tract infection	5.1% 2/39 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumonia	5.1% 2/39 • Number of events 2
Infections and infestations Bladder infection	2.6% 1/39 • Number of events 1
Infections and infestations Wound infection	2.6% 1/39 • Number of events 1
Infections and infestations Skin infection	2.6% 1/39 • Number of events 1
Infections and infestations Infections and infestations -other	5.1% 2/39 • Number of events 2
General disorders Injection site reaction	2.6% 1/39 • Number of events 1
Injury, poisoning and procedural complications Pancreatic anastomotic leak	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Nausea	7.7% 3/39 • Number of events 3
Gastrointestinal disorders Small intestinal obstruction	5.1% 2/39 • Number of events 2
Gastrointestinal disorders Abdominal pain	12.8% 5/39 • Number of events 5
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/39 • Number of events 1
General disorders Pain	2.6% 1/39 • Number of events 1
Renal and urinary disorders Urogenital disorder	5.1% 2/39 • Number of events 2
General disorders Chills	2.6% 1/39 • Number of events 1
Nervous system disorders Syncope	2.6% 1/39 • Number of events 1
Injury, poisoning and procedural complications Vascular access complication	2.6% 1/39 • Number of events 1
Gastrointestinal disorders Vomiting	7.7% 3/39 • Number of events 3

Other adverse events

Other adverse events
Measure	Gemcitabine And Oxaliplatin n=39 participants at risk A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles. protein expression analysis proteomic profiling diagnostic laboratory biomarker analysis adjuvant therapy neoadjuvant therapy therapeutic conventional surgery
Investigations Aspartate aminotransferase increased	7.7% 3/39 • Number of events 3
Investigations Alkaline phosphatase increased	5.1% 2/39 • Number of events 2
General disorders Fatigue	10.3% 4/39 • Number of events 4
Metabolism and nutrition disorders Hyperglycemia	7.7% 3/39 • Number of events 3
Blood and lymphatic system disorders Anemia	23.1% 9/39 • Number of events 9
Investigations White blood cell decreased	20.5% 8/39 • Number of events 8
Investigations Lymphocyte count decreased	12.8% 5/39 • Number of events 5
Gastrointestinal disorders Nausea	7.7% 3/39 • Number of events 3
Investigations Neutrophil count decreased	23.1% 9/39 • Number of events 9
Gastrointestinal disorders Abdominal pain	5.1% 2/39 • Number of events 2

Additional Information

Dr. Eileen O'Reilly

Memorial Sloan-Kettering Cancer Center

Phone: 646-888-4182

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place