Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.

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Detailed Description

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Conditions

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Lung Cancer Pancreatic Cancer Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panitumumab + Gem/Cis

Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

50 mg QD AMG 706 + panitumumab + Gem/Cis

AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

75 mg QD AMG 706 + panitumumab + Gem/Cis

AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

100 mg QD AMG 706 + panitumumab + Gem/Cis

AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

125 mg QD AMG 706 + panitumumab + Gem/Cis

AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

75 mg BID AMG 706 + panitumumab + Gem/Cis

AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Panitumumab

Intervention Type BIOLOGICAL

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Cisplatin

Intervention Type DRUG

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

Interventions

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AMG 706

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Intervention Type DRUG

Panitumumab

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Intervention Type BIOLOGICAL

Gemcitabine

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Intervention Type DRUG

Cisplatin

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

Intervention Type DRUG

Other Intervention Names

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Vectibix Gemzar cisplatinum cis-diamminedichloridoplatinum(II) (CDDP)

Eligibility Criteria

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Inclusion Criteria

* Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
* Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy regimen is clinically indicated
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological function
* Adequate renal function
* Adequate hepatic function
* Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria

* More than 1 prior chemotherapy regimen
* History of venous thrombosis
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year before study enrollment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
* Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood pressure of greater than 85 mm Hg
* Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
* Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab \[Erbitux®\] or EMD 72000)
* Systemic chemotherapy within 28 days before study enrollment
* Major surgery within 28 days or minor surgery within 14 days of study enrollment
* Central nervous system metastases (Exception: subjects with treated asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before the study enrollment are eligible)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No