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Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

NCT02392637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-02-02

Study results available
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Summary

This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Conditions

  • Stage III Intrahepatic Cholangiocarcinoma AJCC v7
  • Stage IIIA Gallbladder Cancer AJCC v7
  • Stage IIIB Gallbladder Cancer AJCC v7
  • Stage IVA Gallbladder Cancer AJCC v7
  • Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7
  • Stage IVB Gallbladder Cancer AJCC v7
  • Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7
  • Unresectable Extrahepatic Bile Duct Carcinoma
  • Unresectable Gallbladder Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nab-paclitaxel

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Milind Javle · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-02
Primary Completion
2020-08-13
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392637 on ClinicalTrials.gov