Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).

Intravenous Infusion (IV), 32 mg/m\^2 every 21 days.

Ixabepilone

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.

Bristol-Myers Squibb

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.

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

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

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.

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.

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.

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.

Overall survival time was defined as the time in months from the first dosing date to the date of death.

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.

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.

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.

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.

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.

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.

EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.

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.

R-Pharm

Ixabepilone + Cetuximab

Age, Continuous

Age Greater than, equal to 65 years

Age less than 65 years

Age, Customized

Sex: Female, Male

Study CA163-116 was completed; however, the combination tested in this trial failed to meet the primary objective to demonstrate a 6-month survival rate greater than 50% in participants with metastatic pancreatic cancer.

Name/Official Title: BMS Study Director

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.

Percentage of Participants Surviving at 6 Months

Participants with Complete Response

Participants with Partial Response

Participants with Stable Disease

Participants with Progressive Disease

Participants with Response Unable to be Determined

Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.

Best Overall Tumor Response

Percentage of Participants With Objective Tumor Response

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.

Median Progression Free Survival Time

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.

Median Overall Survival Time

Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.

Median Duration of Response

Response-evaluable participants whose best response was PR or CR.

Median Time to Response

All deaths within 30 days of last dose

Any SAE

Gr 2 (moderate) AE leading to DC

Gr 3 (severe) AE leading to DC

Gr 4 (life-threatening) AE leading to DC

All AEs leading to DC

Gr 1 (mild) treatment-related AE

Gr 2 (moderate) treatment-related AE

Gr 3 (severe) treatment-related AE

Gr 4 (life-threatening) treatment-related AE

Gr 5 (death) treatment-related AE

All treatment-related AEs

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.

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)

Gr 1 (mild) acneform rash

Gr 2 (moderate) acneform rash

Gr 3 (severe) acneform rash

All acneform rash

Gr 1 (mild) fatigue

Gr 2 (moderate) fatigue

Gr 3 (severe) fatigue

Gr 4 (life-threatening) fatigue

All fatigue

Gr 1 (mild) alopecia

Gr 2 (moderate) alopecia

All alopecia

Gr 1 (mild) nausea

Gr 2 (moderate) nausea

Gr 3 (severe) nausea

All nausea

Gr 1 (mild) diarrhea

Gr 2 (moderate) diarrhea

Gr 3 (severe) diarrhea

Gr 4 (life-threatening) diarrhea

All diarrhea

Gr 1 (mild) vomiting

Gr 2 (moderate) vomiting

Gr 3 (severe) vomiting

All vomiting

Gr 1 (mild) peripheral neuropathy

Gr 2 (moderate) peripheral neuropathy

Gr 3 (severe) peripheral neuropathy

All peripheral neuropathy

Gr 1 (mild) hypomagnesemia

Gr 2 (moderate) hypomagnesemia

Gr 3 (severe) hypomagnesemia

Gr 4 (life-threatening) hypomagnesemia

All hypomagnesemia

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.

Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)

Gr 0 (no abnormality) WBC, n=51

Gr 1 (mild) WBC, n=51

Gr 2 (moderate) WBC, n=51

Gr 3 (severe) WBC, n=51

Gr 4 (life-threatening) WBC, n=51

Gr 1-4 WBC, n=51

Gr 3-4 WBC, n=51

Gr 0 (no abnormality) ANC, n=50

Gr 1 (mild) ANC, n=50

Gr 2 (moderate) ANC, n=50

Gr 3 (severe) ANC, n=50

Gr 4 (life-threatening) ANC, n=50

Gr 1-4 ANC, n=50

Gr 3-4 ANC, n=51

Gr 0 (no abnormality) platelet count, n=51

Gr 1 (mild) platelet count, n=51

Gr 2 (moderate) platelet count, n=51

Gr 1-4 platelet count, n=51

Gr 0 (no abnormality) HGB, n=51

Gr 1 (mild) HGB, n=51

Gr 2 (moderate) HGB, n=51

Gr 3 (severe) HGB, n=51

Gr 1-4 HGB, n=51

Gr 3-4 HGB, n=51

Gr 0 (no abnormality) ALT, n=46

Gr 1 (mild) ALT, n=46

Gr 2 (moderate) ALT, n=46

Gr 3 (severe) ALT, n=46

Gr 1-4 ALT, n=46

Gr 3-4 ALT, n=46

Gr 0 (no abnormality) AST, n=47

Gr 1 (mild) AST, n=47

Gr 3 (severe) AST, n=47

Gr 1-4 AST, n=47

Gr 3-4 AST, n=47

Gr 0 (no abnormality) alkaline phosphatase, n=47

Gr 1 (mild) alkaline phosphatase, n=47

Gr 2 (moderate) alkaline phosphatase, n=47

Gr 3 (severe) alkaline phosphatase, n=47

Gr 1-4 alkaline phosphatase, n=47

Gr 3-4 alkaline phosphatase, n=47

Gr 0 (no abnormality) total bilirubin, n=48

Gr 1 (mild) total bilirubin, n=48

Gr 2 (moderate) total bilirubin, n=48

Gr 3 (severe) total bilirubin, n=48

Gr 1-4 total bilirubin, n=48

Gr 3-4 total bilirubin, n=48

Gr 0 (no abnormality) creatinine, n=48

Gr 1 (mild) creatinine, n=48

Gr 1-4 creatinine, n=48

Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available

Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)

All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks.

All participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).

Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.

Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption

Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.

Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression

Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.

Change From Baseline in FHSI-8 Total Score by Time-point

Overall Study

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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