Trial Outcomes & Findings for Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint (NCT NCT00613730)

Last Updated: 2014-01-06

Results Overview

The survival time is calculated from Study Day 1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

12 months

Results posted on

2014-01-06

Participant Flow

Participants were enrolled from 26 March 2007 through 13 April 2007

Participant milestones

Participant milestones
Measure	Gemcitabine + Panitumumab Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine + Panitumumab Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
Overall Study Disease progression	2
Overall Study Administrative decision	1

Baseline Characteristics

Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine + Panitumumab n=3 Participants Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
Age Continuous	64 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=99 Participants
Race/Ethnicity, Customized White or Caucasian	2 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Study was terminated after enrolling 3 participants. This outcome was not evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 25 months

Population: Study was terminated after enrolling 3 participants. This outcome was not evaluated.

Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician's assessment based on symptom progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Overall study

Population: Study was terminated after enrolling 3 participants. This outcome was not evaluated.

Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine + Panitumumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine + Panitumumab n=3 participants at risk Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
General disorders Asthenia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Bile duct obstruction	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hyperbilirubinaemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Other adverse events
Measure	Gemcitabine + Panitumumab n=3 participants at risk Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m\^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Erythema of eyelid	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eye disorder	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Retinal oedema	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Mouth ulceration	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholangitis	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacterial sepsis	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Paronychia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Respiratory tract infection	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Skin laceration	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	66.7% 2/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Amnesia	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Encephalopathy	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Somnolence	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	66.7% 2/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Disorientation	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Hallucination	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Acute prerenal failure	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sputum increased	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin fissures	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	33.3% 1/3 • First dose through maximum of safety follow-up or 30 days after last dose, up to 25 months. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial resul
Publication restrictions are in place

Restriction type: OTHER