Trial Outcomes & Findings for Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer (NCT NCT00089024)

Last Updated: 2023-09-29

Results Overview

Patients who completed chemotherapy \& chemo-radiation had restaging imaging studies 4 weeks after completion of chemo-radiation. If there were no contraindications for surgical resection, surgical exploration was performed 6-8 weeks after completing chemo-radiation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

Results posted on

2023-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma. Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT.
Overall Study STARTED	29
Overall Study Treated Subjects	29
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=29 Participants neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma. Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	28 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 6 weeks of chemotherapy and then after 4 weeks of chemo-radiation.

Population: Only 19 participants under went surgical exploration.

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants Eligible patients will receive an initial two cycles of chemotherapy with: gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. Radiation therapy: Patients who required no treatment delays will commence chemoradiation on day 42. Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. Resection will be performed six to eight weeks after completing chemoradiation. Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression
Surgical Exploration resection of the primary tumor	9 Participants
Surgical Exploration unresectable disease	4 Participants
Surgical Exploration intra-abdominal metastasis	6 Participants

PRIMARY outcome

Timeframe: From time of first dose until 30 days following final treatment, approximately 24 weeks

Population: A total of 29 patients started induction CT. Two patients dropped out because of progressive disease (PD) and 1 died from pulmonary embolus. 27 patients continued with CRT 24 (89%) received the full radiation dose. Of 24, 5 went off study prior to surgical exploration, for remaining 19 with surgical exploration.

Toxicity event collected during Induction chemotherapy (CT) - two 3-week cycles, Concurrent CT and Radiation Therapy (CRT) (approximately 5.5 weeks), post CRT (4 weeks after the end of CRT), 2-3 months post CRT (8-12 weeks after the end of CRT)

Outcome measures

Outcome measures
Measure	Treatment n=29 Participants Eligible patients will receive an initial two cycles of chemotherapy with: gemcitabine 750 (females) or 900 (males) mg/m5 over 30 minutes followed by a 24-hour infusion of fluorouracil 2700 mg/m5 on days 2 and 9 of a 21-day cycle . Calcium leucovorin 20 mg/m5 will be given orally on days 1 and 8 and by IV push on days 2 and 9 prior to the 5-FU. Radiation therapy: Patients who required no treatment delays will commence chemoradiation on day 42. Restaging with repeat imaging studies will be performed four weeks after completion of the chemo-radiation. Resection will be performed six to eight weeks after completing chemoradiation. Patients who have undergone surgical resection, after post-operative recovery, will receive two additional cycles of gemcitabine/5-FU/leucovorin. If surgical resection is not possible, patients with stable or responsive disease will resume gemcitabine/5-FU/leucovorin and continue on it indefinitely until disease progression
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment Induction CT, grade 3	4 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment Induction CT, grade 4	5 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment CRT, grade 4	0 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment Within 1 mo. post CRT, grade 3	12 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment CRT, grade 3	11 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment Within 1 mo. post CRT, grade 4	1 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment 2-3 mos. post CRT, grade 3	9 Participants
Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment 2-3 mos. post CRT, grade 4	0 Participants

Adverse Events

Treatment

Serious events: 25 serious events

Other events: 27 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=29 participants at risk neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma. Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hyponatremia	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Infections and infestations Sepsis	13.8% 4/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Cardiac disorders Myocardial infarction	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hypokalemia	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Acidosis	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Vascular disorders Vascular disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Investigations Investigations - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Dehydration	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Vomiting	13.8% 4/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Blood and lymphatic system disorders Anemia	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Diarrhea	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Infections and infestations Infections and infestations - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Ascites	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hypoalbuminemia	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hypocalcemia	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Gastrointestsinal disorders - other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Gastrointestinal disorders- Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Gastric perforation	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Nervous system disorders Nervous system disorders - Other, specify	3.4% 1/29 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)

Other adverse events

Other adverse events
Measure	Treatment n=29 participants at risk neoadjuvant regimen involving gemcitabine, infusional 5-fluorouracil (5-FU), oxaliplatin and radiation therapy (RT) in patients with potentially resectable locally advanced pancreatic adenocarcinoma. Induction chemotherapy (CT) consisted of two 3-week cycles of weekly gemcitabine with 24-hour continuous infusion of 5 FU for 2 of 3 weeks. Chemoradiation (CRT) consisted of RT of 50.4 Gy in 28 fractions or 50 Gy in 25 fractions and weekly oxaliplatin with 24-hour continuous infusion of 5 FU throughout RT. The first 7 patients also received celecoxib 200 mg BID throughout induction CT and CRT.
Vascular disorders Thromboembolic event	27.6% 8/29 • Number of events 9 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
General disorders Fatigue	24.1% 7/29 • Number of events 8 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	13.8% 4/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Nausea	17.2% 5/29 • Number of events 5 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Investigations Hemoglobin	27.6% 8/29 • Number of events 9 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	6.9% 2/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hyponatremia	34.5% 10/29 • Number of events 15 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Infections and infestations Urinary tract infection	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Investigations Investigations - Other, specify	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hypokalemia	41.4% 12/29 • Number of events 22 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
General disorders General disorders and administration site conditions - Other, specify	10.3% 3/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Dehydration	6.9% 2/29 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Abdominal Pain	10.3% 3/29 • Number of events 6 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Renal and urinary disorders Renal and urinary disorders - Other, specity	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Anorexia	13.8% 4/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Diarrhea	10.3% 3/29 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Dysphagia	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hyperglycemia	13.8% 4/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Metabolism and nutrition disorders Hypoalbuminemia	20.7% 6/29 • Number of events 7 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Vascular disorders Vascular disorders - Other, specify	6.9% 2/29 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Infections and infestations Sepsis	10.3% 3/29 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Gastrointestinal disorders Vomiting	10.3% 3/29 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)
Investigations Weight loss	10.3% 3/29 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 24 weeks)

Additional Information

Jean L Grem

University of Nebraska Medical Center

Phone: 402-552-3233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place