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

Brief summary public domain (ClinicalTrials.gov)

Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS) [Time from randomization to disease progression or death from any cause (Range: 0 -10 months)]. Median, months (95% Confidence Interval). Cetuximab + Bevacizumab + Gemcitabine (n=29): 3.55 (2.00 to 5.59); Cetuximab + Bevacizumab (n=29): 1.91 (1.81 to 2.76).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).]. Median, Months (95% Confidence Interval). Cetuximab + Bevacizumab + Gemcitabine (n=29): 5.41 (3.84 to 6.74); Cetuximab + Bevacizumab (n=29): 4.17 (2.69 to 8.74).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) [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.]. Number, Participants. Cetuximab + Bevacizumab + Gemcitabine (n=29): 4 (3.9 to 31.7); Cetuximab + Bevacizumab (n=29): 0 (0.1 to 17.8).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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). [First day of treatment to the end of Cycle 2, Week 1]. Number, Percentage of participants. Cetuximab + Bevacizumab + Gemcitabine (n=18): 8; Cetuximab + Bevacizumab (n=19): 9.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Progression (TTP) [Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)]. Median, months (95% Confidence Interval). Cetuximab + Bevacizumab + Gemcitabine (n=29): 4.11 (2.17 to 5.95); Cetuximab + Bevacizumab (n=29): 2.07 (1.84 to 4.01).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [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.]. Number, Participants. Cetuximab + Bevacizumab + Gemcitabine (n=29): 29; Cetuximab + Bevacizumab (n=29): 29.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.9 (2.9); Cetuximab + Bevacizumab (n=12): -0.9 (2.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): 0.6 (2.0); Cetuximab + Bevacizumab (n=11): -0.8 (1.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.6 (3.1); Cetuximab + Bevacizumab (n=12): -0.6 (1.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.2 (2.8); Cetuximab + Bevacizumab (n=11): -1.1 (2.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -1.1 (2.9); Cetuximab + Bevacizumab (n=12): 0.6 (2.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.4 (1.8); Cetuximab + Bevacizumab (n=11): -0.3 (1.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -1.5 (2.9); Cetuximab + Bevacizumab (n=12): -2.3 (2.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.5 (2.8); Cetuximab + Bevacizumab (n=12): -0.9 (2.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): 1.5 (2.3); Cetuximab + Bevacizumab (n=12): 0.3 (2.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): 0.1 (1.3); Cetuximab + Bevacizumab (n=12): -0.8 (1.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.1 (2.4); Cetuximab + Bevacizumab (n=12): 0.9 (3.7).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): 0.4 (1.7); Cetuximab + Bevacizumab (n=12): 2.3 (3.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -1.2 (2.8); Cetuximab + Bevacizumab (n=12): 0.5 (2.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.4 (2.0); Cetuximab + Bevacizumab (n=12): 0.9 (2.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.6 (1.8); Cetuximab + Bevacizumab (n=12): -0.2 (2.1).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=17): -0.9 (2.6); Cetuximab + Bevacizumab (n=12): 0.9 (2.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4 [Screening, and then every 8 weeks while receiving study drug to 30-day follow-up]. Mean, Scores on a scale (Standard Deviation). Cetuximab + Bevacizumab + Gemcitabine (n=16): -0.2 (2.3); Cetuximab + Bevacizumab (n=12): 0.8 (2.9).