Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from a population of pancreatic cancer patients treated at investigational centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior chemotherapy, hormonal therapy, radiation therapy in the adjuvant setting were allowed, provided that the last date of therapy was at least 6 months prior to randomization.

Reporting Groups

	Description
Cetuximab + Bevacizumab + Gemcitabine	Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab	Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Participant Flow:   Overall Study

	Cetuximab + Bevacizumab + Gemcitabine	Cetuximab + Bevacizumab
STARTED	30 [1]	31 [1]
COMPLETED	29 [2]	29 [2]
NOT COMPLETED	1	2
Hospitalization prior to treatment	0	1
Physician decision prior to treatment	1	0
Withdrawal by subject prior to treatment	0	1

Reporting Groups

	Description
Cetuximab + Bevacizumab + Gemcitabine	Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Cetuximab + Bevacizumab	Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
Total	Total of all reporting groups

Baseline Measures

	Cetuximab + Bevacizumab + Gemcitabine	Cetuximab + Bevacizumab	Total
Number of Participants   [units: participants]	30	31	61
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	18	18	36
>=65 years	12	13	25
Age   [units: years] Mean ± Standard Deviation	62.7  ± 11.6	62.2  ± 11.4	62.4  ± 11.4
Gender   [units: participants]
Female	11	15	26
Male	19	16	35
Region of Enrollment   [units: participants]
United States	30	31	61

1.  Primary:

Progression-free Survival (PFS)   [ Time Frame: Time from randomization to disease progression or death from any cause (Range: 0 -10 months) ]

2.  Secondary:

Overall Survival (OS)   [ Time Frame: Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months). ]

3.  Secondary:

The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)   [ Time Frame: Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. ]

4.  Secondary:

Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).   [ Time Frame: First day of treatment to the end of Cycle 2, Week 1 ]

5.  Secondary:

Time to Progression (TTP)   [ Time Frame: Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months) ]

6.  Secondary:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

7.  Secondary:

Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

8.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

9.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

10.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

11.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

12.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug ]

13.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

14.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug ]

15.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

16.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

17.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

18.  Secondary:

Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

19.  Secondary:

Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

20.  Secondary:

Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

21.  Secondary:

Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

22.  Secondary:

Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]

23.  Secondary:

Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4   [ Time Frame: Screening, and then every 8 weeks while receiving study drug to 30-day follow-up ]