Trial Outcomes & Findings for Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer (NCT NCT00417976)

NCT ID: NCT00417976

Last Updated: 2015-10-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-10-01

Participant Flow

Participant milestones

Measure	Bevacizumab Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab : 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.
Overall Study STARTED	42
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Bevacizumab Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab : 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.
Overall Study Non compliance unrelated to toxicity	1
Overall Study Treatment -related toxicity	2

Baseline Characteristics

Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

Baseline characteristics by cohort

Measure	Bevacizumab n=42 Participants Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab : 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance status 0 (Fully Active)	15 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance status 1 (Restricted in physical activity)	27 participants n=5 Participants
Site of metastasis Liver only	29 participants n=5 Participants
Site of metastasis Liver+other	2 participants n=5 Participants
Site of metastasis Other only	9 participants n=5 Participants
Site of metastasis Recurrent metastatic disease	2 participants n=5 Participants
Prior adjuvant therapy Gemcitabine-based	1 participants n=5 Participants
Prior adjuvant therapy Chemoraditation	1 participants n=5 Participants
Prior adjuvant therapy No prior adjuvant therapy	40 participants n=5 Participants
Disease stage III (Unresectable primary tumor)	2 participants n=5 Participants
Disease stage IV (Cancer has spread o distant tissue or organ)	40 participants n=5 Participants
CA19-9 (tumor marker levels) Normal (≤37 U/ml)	6 participants n=5 Participants
CA19-9 (tumor marker levels) Elevated (>37 U/ml)	36 participants n=5 Participants
Albumin Normal (≥3.4 g/dl)	28 participants n=5 Participants
Albumin Low (<3.4 g/dl)	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Bevacizumab n=39 Participants Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab : 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.
Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy	49 percent of patients

SECONDARY outcome

Timeframe: 6 months

The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients

Outcome measures

Measure	Bevacizumab n=40 Participants Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab : 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.
Response Rates Defined by RECIST 1.0 Complete Respsonse	0 patients
Response Rates Defined by RECIST 1.0 Partial Response	12 patients
Response Rates Defined by RECIST 1.0 Stable Disease	18 patients
Response Rates Defined by RECIST 1.0 Progressive Disease	10 patients

Adverse Events

Bevacizumab

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab n=42 participants at risk Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab: 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks.
Blood and lymphatic system disorders Anemia	2.4% 1/42 • Number of events 1 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.

Other adverse events

Measure	Bevacizumab n=42 participants at risk Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks. Bevacizumab: 10 mg/kg every 2 weeks. Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks.
Blood and lymphatic system disorders Anemia	64.3% 27/42 • Number of events 27 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Injury, poisoning and procedural complications Thrombocytopenia	31.0% 13/42 • Number of events 13 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Investigations Leukopenia	26.2% 11/42 • Number of events 11 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Investigations Neutropenia	14.3% 6/42 • Number of events 6 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Investigations Lymphopenia	19.0% 8/42 • Number of events 8 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
General disorders Fatigue	61.9% 26/42 • Number of events 26 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Gastrointestinal disorders Vomiting	78.6% 33/42 • Number of events 33 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Gastrointestinal disorders Nausea	59.5% 25/42 • Number of events 25 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Gastrointestinal disorders Diarrhea	38.1% 16/42 • Number of events 16 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Investigations Elevated ALT, SGPT (serum glutamic pyruvic transaminase)	16.7% 7/42 • Number of events 7 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Investigations Elevated AST, SGOT(serum glutamic oxaloacetic transaminase)	14.3% 6/42 • Number of events 6 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Gastrointestinal disorders Mucositis	21.4% 9/42 • Number of events 9 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Nervous system disorders Altered sense of taste	28.6% 12/42 • Number of events 12 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Vascular disorders Hypertension	19.0% 8/42 • Number of events 8 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Gastrointestinal disorders Fistula formation	2.4% 1/42 • Number of events 1 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Renal and urinary disorders Proteinuria	7.1% 3/42 • Number of events 3 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Vascular disorders Bleeding	16.7% 7/42 • Number of events 7 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Vascular disorders Thrombosis	4.8% 2/42 • Number of events 2 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Nervous system disorders Headache	11.9% 5/42 • Number of events 5 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Skin and subcutaneous tissue disorders Rash	11.9% 5/42 • Number of events 5 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Nervous system disorders Peripheral sensory neuropathy	14.3% 6/42 • Number of events 6 • Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.

Additional Information

Tanios Bekaii-Saab

The Ohio State University

Phone: 614-293-9863

Email: Tanios.saab@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place