Trial Outcomes & Findings for Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer (NCT NCT00225784)

NCT ID: NCT00225784

Last Updated: 2014-07-16

Results Overview

Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: one month post-therapy
• Results posted on: 2014-07-16

Participant Flow

This was a single-institution study of weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with pancreatic ductal adenocarcinoma conducted at Dartmouth-Hitchcock.

Participant milestones

Measure	Cetuximab, Gemcitabine, Radiotherapy Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Overall Study STARTED	37
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Baseline characteristics by cohort

Measure	Cetuximab/Gemcitabine/Radiotherapy n=37 Participants weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Age, Continuous Between 18 and 65 years	54.7 years n=5 Participants
Age, Continuous >=65 years	73.1 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: one month post-therapy

Population: Completion of treatment

Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=33 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Objective Response of Tumor by RECIST 1.0 Criteria partial response	10 participants	—
Objective Response of Tumor by RECIST 1.0 Criteria stable disease	20 participants	—
Objective Response of Tumor by RECIST 1.0 Criteria progressive disease	3 participants	—

SECONDARY outcome

Timeframe: Participants were followed during treatment and for 30 days after completion of treatment

Population: All participants were evaluated for toxicity.

Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=37 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Number of Participants Assessed for Adverse Events	37 participants	—

SECONDARY outcome

Timeframe: 1 month after completion of treatment

Population: Surviving participants who completed therapy and were determined to be resectable.

Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=33 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy	26 participants	—

SECONDARY outcome

Timeframe: One month post-therapy

Population: All EGFR (-) subjects who completed therapy were evaluated.

Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=9 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors n=24 Participants Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.	33 percent	29 percent

SECONDARY outcome

Timeframe: Five years post treatment

Population: All evaluable participants who completed treatment, and had confirmed progression of disease.

Time to disease progression after therapy.

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=28 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Disease-Free Survival After Therapy	9.1 months Interval 2.0 to Partipants did not all reach endpoint.	—

SECONDARY outcome

Timeframe: Five years post treatment

Population: All participants enrolled regardless of evaluability for primary outcome measure.

Length of survival after therapy in all participants enrolled.

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=37 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Overall Length of Survival After Therapy	17.3 months Interval 2.0 to Not all participants evaluated reached end point.	—

SECONDARY outcome

Timeframe: Five years post treatment

Population: All participants who completed treatment and underwent resection

Local recurrence, distant recurrence, or both.

Outcome measures

Measure	Cetuximab, Gemcitabine, Radiotherapy n=25 Participants Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.	Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
Pattern of Failure After Therapy number of participants with local recurrence only	2 participants	—
Pattern of Failure After Therapy number of ppts. with local and distant recurrence	1 participants	—
Pattern of Failure After Therapy number of ppts. with distant disease recurrence	17 participants	—
Pattern of Failure After Therapy number of ppts. without recurrence or unknown	5 participants	—

Adverse Events

Cetuximab/Gemcitabine/Radiotherapy

Serious events: 22 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cetuximab/Gemcitabine/Radiotherapy n=33 participants at risk weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Nervous system disorders CNS Ischemia	6.1% 2/33 • Number of events 2
Investigations Anemia	3.0% 1/33 • Number of events 1
Gastrointestinal disorders Gastrointestinal disorder - stent obstruction	24.2% 8/33 • Number of events 8
Vascular disorders Deep vein thrombosis	6.1% 2/33 • Number of events 2
General disorders Fatigue	12.1% 4/33 • Number of events 4
Gastrointestinal disorders Gastritis/GI Bleed	15.2% 5/33 • Number of events 5
Nervous system disorders Hematoma subdural	3.0% 1/33 • Number of events 1
Gastrointestinal disorders Nausea/Vomiting	27.3% 9/33 • Number of events 16
Musculoskeletal and connective tissue disorders Pain - gouty arthritis	3.0% 1/33 • Number of events 1
Blood and lymphatic system disorders Neutropenia	66.7% 22/33 • Number of events 34

Other adverse events

Measure	Cetuximab/Gemcitabine/Radiotherapy n=33 participants at risk weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Immune system disorders Anaphylaxtic reaction to erbitux	8.1% 3/37 • Number of events 3

Additional Information

J. Marc Pipas, MD

Dartmouth-Hitchcock

Phone: 603-650-9474

Email: J.Marc.Pipas@hitchcock.org

Results disclosure agreements

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