Trial Search Results

Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers

This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, 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. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Southwest Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Cisplatin
  • Drug: Gemcitabine Hydrochloride
  • Drug: Nab-paclitaxel

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have histologically or cytologically confirmed intrahepatic
   cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer

      - NOTE: Pathology report must be uploaded in Rave. Histology report must be
      consistent with an adenocarcinoma with pancreaticobiliary primary assuming there
      are no pancreatic lesions and other primaries are ruled out per local standard

   - Patients must have documented metastatic or locally advanced unresectable disease on
   computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to
   assess measurable disease. Must have been completed within 28 days prior to
   registration. CT scans or MRIs used to assess non-measurable disease must have been
   completed within 42 days prior to registration. All disease must be assessed and
   documented on the Baseline Tumor Assessment Form

   - Patient must not have a current diagnosis of ampullary cancer

   - Patients must not have received prior systemic therapy for the current metastatic or
   locally advanced biliary cancer

   - Patient must not have received adjuvant therapy within 6 months prior to registration

   - Patients must have a complete medical history and physical exam within 28 days prior
   to registration

   - Patients must have a Zubrod performance status of 0 or 1

   - Patients must not have a history of peripheral neuropathy of grade 2 or greater by
   Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade
   2 sensory neuropathy is defined as ?moderate symptoms; limiting instrumental
   activities of daily living (ADLs)?

   - Absolute neutrophil count (ANC) >= 1,500/mcL (obtained within 28 days prior to
   registration)

   - Platelets >= 100,000/mcL (obtained within 28 days prior to registration)

   - Hemoglobin >= 8 g/dL (obtained within 28 days prior to registration)

   - Serum albumin >= 2.8 g/dL (obtained within 28 days prior to registration)

   - Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients
   with Gilbert?s syndrome, who must have a direct bilirubin < 1.5 mg/dL) (obtained
   within 28 days prior to registration)

   - Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
   serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 8 x
   IULN (obtained within 28 days prior to registration)

   - Serum creatinine =< IULN OR calculated creatinine clearance >= 60 mL/min (obtained
   within 28 days prior to registration)

   - Patients must have CA19-9 obtained within 42 days prior to registration

   - Patients must have sodium, potassium, bicarbonate, chloride, blood urea nitrogen
   (BUN), calcium, total protein, magnesium, and alkaline phosphatase obtained within 28
   days prior to registration

   - Patients must not have an active infection requiring systemic therapy

   - No other prior malignancy is allowed except for the following: adequately treated
   basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
   stage I or II cancer from which the patient is currently in complete remission, or any
   other cancer from which the patient has been disease free for two years

   - Patients must not be pregnant or nursing. Women/men of reproductive potential must
   have agreed to use an effective contraceptive method. A woman is considered to be of
   "reproductive potential" if she has had menses at any time in the preceding 12
   consecutive months. In addition to routine contraceptive methods, "effective
   contraception" also includes heterosexual celibacy and surgery intended to prevent
   pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
   bilateral oophorectomy or bilateral tubal ligation. However, if at any point a
   previously celibate patient chooses to become heterosexually active during the time
   period for use of contraceptive measures outlined in the protocol, he/she is
   responsible for beginning contraceptive measures

   - Sites must seek additional patient consent for the future use of specimens

   - Patients must be informed of the investigational nature of this study and must sign
   and give written informed consent in accordance with institutional and federal
   guidelines

   - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
   treating institution's identity is provided in order to ensure that the current
   (within 365 days) date of institutional review board approval for this study has been
   entered in the system

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Umara Ahmed
650-498-6608
Not Recruiting