A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Phase II, Open Label Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383149
• Other study ID #: CA163-116
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2006
• Last updated: February 9, 2016
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: February 2016
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Ixabepilone
Intravenous Infusion (IV), 32 mg/m^2 every 21 days.
• Cetuximab
Initial dose of 400 mg/m^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m^2 IV over 1 hour.

Locations

Country	Name	City	State
United States	University Of Michigan	Ann Arbor	Michigan
United States	Ellis Fischel Cancer Center	Columbia	Missouri
United States	Wayne State University	Detroit	Michigan
United States	Cancer Centers Of The Carolinas	Greenville	South Carolina
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University Of Miami	Miami	Florida
United States	West Virginia University	Morgantown	West Virginia
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Georgetn Univ Lombardi Can Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Surviving at 6 Months	The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.	From time of first dose of study drug through 6 months	No
Secondary	Best Overall Tumor Response	Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.	From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)	No
Secondary	Percentage of Participants With Objective Tumor Response	Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.	From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression	No
Secondary	Median Progression Free Survival Time	Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.	From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression	No
Secondary	Median Overall Survival Time	Overall survival time was defined as the time in months from the first dosing date to the date of death.	From the first dosing date until death (last reported death was 21 months after first dose).	No
Secondary	Median Duration of Response	Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.	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).	No
Secondary	Median Time to Response	Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.	Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.	Yes
Secondary	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)	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.	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.	Yes
Secondary	Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.	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.	Yes
Secondary	Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)	Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.	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.	Yes
Secondary	Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption	Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.	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.	Yes
Secondary	Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression	EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.	Baseline	No
Secondary	Change From Baseline in FHSI-8 Total Score by Time-point	The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.	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)	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form