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

NCT00478140 | Terminated Phase 2 Results DMC

• 3 other identifiers: NCI-2009-002172006-0851N01CM62202
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them

Conditions

Adenocarcinoma of the Extrahepatic Bile Duct; Adenocarcinoma of the Gallbladder; Malignant Neoplasm; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response (Complete and Partial Response)

  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.

  Baseline to 63 days or until disease progression

Secondary Outcomes (3)

• Disease Control Rate

  Up to 3.5 years

• Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  Up to 3 years

• Overall Survival

  Up to 3.5 years

Study Arms (1)

Trastuzumab

EXPERIMENTAL

Participants receive 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.

Biological: trastuzumab; Other: laboratory biomarker analysis

Interventions

trastuzumab BIOLOGICAL

For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.

Also known as: anti-c-erB-2, Herceptin, MOAB HER2

Trastuzumab

laboratory biomarker analysis OTHER

Correlative studies

Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Criteria: * Adenocarcinoma of the gallbladder * Recurrent extrahepatic bile duct cancer * Recurrent gallbladder cancer * Unresectable extrahepatic bile duct cancer * Adenocarcinoma of the extrahepatic bile duct * Unresectable gallbladder cancer * Prior surgery and radiotherapy allowed * At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered * No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy * Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed * No concurrent corticosteroids or anticonvulsants * Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria: locally advanced or metastatic disease that is unresectable * Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques or \>= 10 mm by spiral computed tomography (CT) scan * Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing * No symptomatic brain metastases * The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100% * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Fertile patients must use effective contraception prior to, during, and for \>= 3 months after completion of study treatment * Creatinine =\< 2 times upper limits of normal (ULN) OR creatinine clearance \>= 60 mL/min * No other active malignancy * Left Ventricular Ejection Fraction (LVEF) \>= 50% * No concurrent uncontrolled illness * No ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment * No symptomatic New York Heart Association class III-IV congestive heart failure * No unstable angina pectoris * No unstable cardiac arrhythmia requiring medication * No more than 1 prior systemic chemotherapy regimen * White Blood Count (WBC) \>= 3,000/mm\^3 * Platelet count \>= 40,000/mm\^3 * Bilirubin =\< 4 mg/dL * Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\< 5 times upper limit of normal (ULN) * Not pregnant or nursing * Negative pregnancy test

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

The University of Texas (UT) MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas MD Anderson Cancer Center official website

MeSH Terms

Conditions

Neoplasms; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Ahmed Kaseb / Associate Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

akaseb@mdanderson.org

713-792-2828

Study Officials

• Ahmed Kaseb

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 20, 2019
• Results First Posted: November 19, 2013

Record last verified: 2019-07

Locations

US (2)