Trial Outcomes & Findings for Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery (NCT NCT00478140)

Last Updated: 2019-08-20

Results Overview

Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline to 63 days or until disease progression

Results posted on

2019-08-20

Participant Flow

Recruitment Period: May 30, 2007 to June 15, 2009. All recruitment done in medical clinics.

Of the 53 participants pre-screened only four participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Trastuzumab Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Trastuzumab Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Clinical Disease Progression	1

Baseline Characteristics

Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trastuzumab n=4 Participants Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 63 days or until disease progression

Population: Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable.

Outcome measures

Outcome measures
Measure	Trastuzumab n=3 Participants Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Objective Response (Complete and Partial Response) Complete Response	1 participants
Objective Response (Complete and Partial Response) Partial Response	0 participants
Objective Response (Complete and Partial Response) Progressive Disease	1 participants
Objective Response (Complete and Partial Response) Stable Disease	1 participants

SECONDARY outcome

Timeframe: Up to 3.5 years

Percentage of participants who have achieved complete response, partial response and stable disease

Outcome measures

Outcome measures
Measure	Trastuzumab n=3 Participants Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Disease Control Rate	67 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years

Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.

Outcome measures

Outcome measures
Measure	Trastuzumab n=3 Participants Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	3 participants

SECONDARY outcome

Timeframe: Up to 3.5 years

Length of time from date of starting treatment that participants are still alive

Outcome measures

Outcome measures
Measure	Trastuzumab n=3 Participants Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	65 weeks Interval 9.4 to 127.0

Adverse Events

Trastuzumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trastuzumab n=4 participants at risk Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal distension	50.0% 2/4 • 2 years and 9 months
Gastrointestinal disorders Abdominal pain	75.0% 3/4 • 2 years and 9 months
Immune system disorders Allergic reaction	50.0% 2/4 • 2 years and 9 months
Immune system disorders Allergic rhinitis	50.0% 2/4 • 2 years and 9 months
Gastrointestinal disorders Anorexia	75.0% 3/4 • 2 years and 9 months
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • 2 years and 9 months
Gastrointestinal disorders Ascites	75.0% 3/4 • 2 years and 9 months
Gastrointestinal disorders Diarrhea	50.0% 2/4 • 2 years and 9 months
General disorders Fatigue	100.0% 4/4 • 2 years and 9 months
Gastrointestinal disorders Gastrointestinal disorders	50.0% 2/4 • 2 years and 9 months
General disorders Insomnia	75.0% 3/4 • 2 years and 9 months
Gastrointestinal disorders Nausea	100.0% 4/4 • 2 years and 9 months
Gastrointestinal disorders Vomiting	75.0% 3/4 • 2 years and 9 months
Investigations Weight loss	50.0% 2/4 • 2 years and 9 months
Blood and lymphatic system disorders Alkaline phosphatase increased	50.0% 2/4 • 2 years and 9 months
Blood and lymphatic system disorders Blood bilirubin increased	75.0% 3/4 • 2 years and 9 months
Gastrointestinal disorders Constipation	75.0% 3/4 • 2 years and 9 months
Blood and lymphatic system disorders Creatinine increased	25.0% 1/4 • 2 years and 9 months
Metabolism and nutrition disorders Dehydration	50.0% 2/4 • 2 years and 9 months
Nervous system disorders Dizziness	25.0% 1/4 • 2 years and 9 months
Gastrointestinal disorders Dysgeusia	25.0% 1/4 • 2 years and 9 months
Infections and infestations Fever	25.0% 1/4 • 2 years and 9 months
General disorders Headache	75.0% 3/4 • 2 years and 9 months
Blood and lymphatic system disorders Hyperkalemia	25.0% 1/4 • 2 years and 9 months
Blood and lymphatic system disorders Hyponatremia	25.0% 1/4 • 2 years and 9 months
Respiratory, thoracic and mediastinal disorders Mucositis oral	25.0% 1/4 • 2 years and 9 months
Cardiac disorders Myalgia	50.0% 2/4 • 2 years and 9 months
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • 2 years and 9 months
Infections and infestations Upper respiratory infection	25.0% 1/4 • 2 years and 9 months
Blood and lymphatic system disorders Alanine aminotransferase increased	25.0% 1/4 • 2 years and 9 months
Psychiatric disorders Anxiety	25.0% 1/4 • 2 years and 9 months
Blood and lymphatic system disorders Aspartate aminotransferase increased	50.0% 2/4 • 2 years and 9 months
Musculoskeletal and connective tissue disorders Back pain	50.0% 2/4 • 2 years and 9 months
Investigations Chills	50.0% 2/4 • 2 years and 9 months
Renal and urinary disorders Cystitis noninfective	25.0% 1/4 • 2 years and 9 months
Blood and lymphatic system disorders Hematuria	25.0% 1/4 • 2 years and 9 months
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • 2 years and 9 months
Blood and lymphatic system disorders Anemia	25.0% 1/4 • 2 years and 9 months
Nervous system disorders Hyperhidrosis	25.0% 1/4 • 2 years and 9 months
Musculoskeletal and connective tissue disorders Joint range of motion decreased lumbar spine	25.0% 1/4 • 2 years and 9 months
Musculoskeletal and connective tissue disorders Neck pain	25.0% 1/4 • 2 years and 9 months
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • 2 years and 9 months
Ear and labyrinth disorders Tinnitus	25.0% 1/4 • 2 years and 9 months

Additional Information

Dr. Ahmed Kaseb / Associate Professor

The University of Texas (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