Trial Outcomes & Findings for Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT00416793)

Last Updated: 2019-10-31

Results Overview

Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

up to 6 months

Results posted on

2019-10-31

Participant Flow

Recruitment period: December 7, 2006 to August 26, 2008. All recruitment was done at UT MD Anderson Cancer Center.

The study was terminated early since the protocol met prospective criteria for early stopping.

Participant milestones

Participant milestones
Measure	Bortezomib + Carboplatin Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bortezomib + Carboplatin n=9 Participants Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Age, Continuous	49 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	9 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: Analysis was per protocol; Limited analysis due to study early termination.

Outcome measures

Outcome measures
Measure	Bortezomib + Carboplatin n=9 Participants Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Overall Survival Rate at 6 Months	0 Proportion of participants

SECONDARY outcome

Timeframe: from assignment of treatment until the date of first documented progression, assessed up to 17 months

Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.

Outcome measures

Outcome measures
Measure	Bortezomib + Carboplatin n=9 Participants Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Overall Response Rate	0 Participants

Adverse Events

Bortezomib + Carboplatin

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bortezomib + Carboplatin n=9 participants at risk Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
Gastrointestinal disorders Abdominal Pain	44.4% 4/9 • 17 months
Gastrointestinal disorders Alopecia	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Anorexia	66.7% 6/9 • 17 months
Metabolism and nutrition disorders Aspartate Aminotransferase increased	11.1% 1/9 • 17 months
Hepatobiliary disorders Bile duct stenosis	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Bilirubin increased	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Blood Glucose Increase	44.4% 4/9 • 17 months
Metabolism and nutrition disorders Blood uric acid increased	11.1% 1/9 • 17 months
Eye disorders Blurred vision	11.1% 1/9 • 17 months
Cardiac disorders Cardiac Pain	22.2% 2/9 • 17 months
General disorders Chills	11.1% 1/9 • 17 months
Gastrointestinal disorders Constipation	55.6% 5/9 • 17 months
Metabolism and nutrition disorders Creatinine increased	11.1% 1/9 • 17 months
Nervous system disorders Depression	22.2% 2/9 • 17 months
Gastrointestinal disorders Diarrhea	44.4% 4/9 • 17 months
General disorders Dizziness	11.1% 1/9 • 17 months
Respiratory, thoracic and mediastinal disorders Dyspnea	44.4% 4/9 • 17 months
Skin and subcutaneous tissue disorders Erythema multiform	11.1% 1/9 • 17 months
General disorders Fatigue	55.6% 5/9 • 17 months
Gastrointestinal disorders Gastrointestinal Pain	11.1% 1/9 • 17 months
General disorders Headache	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Increased Alkaline Phosphatase	55.6% 5/9 • 17 months
General disorders Insomnia	22.2% 2/9 • 17 months
Gastrointestinal disorders Mucositis (oral)	11.1% 1/9 • 17 months
Cardiac disorders Myocardial Ischemia	11.1% 1/9 • 17 months
Gastrointestinal disorders Nausea	55.6% 5/9 • 17 months
Musculoskeletal and connective tissue disorders Pain(back)	22.2% 2/9 • 17 months
Musculoskeletal and connective tissue disorders Peripheral Sensory Neuropathy	22.2% 2/9 • 17 months
Blood and lymphatic system disorders Plate Count decrease	55.6% 5/9 • 17 months
Renal and urinary disorders Renal(loss of feeling of urination)	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Serum Sodium increased	11.1% 1/9 • 17 months
Metabolism and nutrition disorders Serum magnesium decreased	11.1% 1/9 • 17 months
General disorders Taste Alteration	44.4% 4/9 • 17 months
Vascular disorders Thrombosis	11.1% 1/9 • 17 months
Gastrointestinal disorders Vomiting	44.4% 4/9 • 17 months

Additional Information

Gauri Varadhachary, MD Associate Professor

UT MD Anderson Cancer Center

Phone: 713-792-2828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60