Clinical trial NCT00383149: A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
Official title: A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
* Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
* Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer
* Karnofsky performance status (KPS) of 70-100
* Adequate hematologic, hepatic and renal function

Primary outcomes:
measure: Percentage of Participants Surviving at 6 Months
timeFrame: From time of first dose of study drug through 6 months
Secondary outcomes:
measure: Best Overall Tumor Response
timeFrame: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)
measure: Percentage of Participants With Objective Tumor Response
timeFrame: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
measure: Median Progression Free Survival Time
timeFrame: From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression
measure: Median Overall Survival Time
timeFrame: From the first dosing date until death (last reported death was 21 months after first dose).
measure: Median Duration of Response
timeFrame: From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).
measure: Median Time to Response
timeFrame: Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.
measure: Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)
timeFrame: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
measure: Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)
timeFrame: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
measure: Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)
timeFrame: From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.
measure: Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption
timeFrame: From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.
measure: Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression
timeFrame: Baseline
measure: Change From Baseline in FHSI-8 Total Score by Time-point
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetn Univ Lombardi Can Ctr
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Greenville
country: United States
facility: Cancer Centers Of The Carolinas
state: South Carolina
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: