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Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

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ClinicalTrials.gov Identifier: NCT02392637
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to gemcitabine and cisplatin can help to control metastatic (has spread) or unresectable (cannot be removed by surgery) biliary cancer. The safety of this drug combination will also be studied.

This is an investigational study. Abraxane is FDA approved and commercially available for the treatment of melanoma, breast, pancreatic, and lung cancer. The use of abraxane in patients with biliary cancer is considered investigational.

Gemcitabine is FDA approved and commercially available for the treatment of ovarian, biliary, and pancreatic cancer. Cisplatin is FDA approved and commercially available for the treatment of osteosarcoma, lung cancer, biliary cancer, and malignant fibrous histiocytoma.

Up to 60 participants will be enrolled in this multicenter study. Up to 50 will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Abraxane (Nab-Paclitaxel) Drug: Cisplatin Drug: Gemcitabine Behavioral: Phone Calls Phase 2

Detailed Description:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drugs in 21-day study cycles.

You will receive all 3 drugs by vein on Days 1 and 8 of each cycle over about 2 hours total. You will receive abraxane first, followed by cisplatin, and then gemcitabine.

Study Visits:

On Days 1 and 8 of each cycle:

  • You will have a physical exam.
  • Blood (about 2 tablespoons) will be drawn for routine tests.

At the end of every 3rd cycle (Cycles 3, 6, 9, and so on), you will have MRI or CT scans. If the disease appears to get better, you will have another scan about 3 cycles later.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the last scan during long-term follow-up.

End-of-Treatment Visit:

Within 10 days after you stop taking the study drugs:

  • You will have a physical exam.
  • Blood (about 2 tablespoons) will be drawn for routine tests.
  • If you have not had one in the last 4 weeks, you will have MRI or CT scans.

Follow-Up:

About 30 days after your last dose of the study drugs, the study staff will ask about any symptoms or side effects you may be having, either by phone or during a routine clinic visit. If you are called, it should last about 15-30 minutes.

Long-Term Follow-Up:

About every 12 weeks after the end-of-treatment visit, if you leave the study for any reason other than the disease getting worse, you will have an MRI or CT scan to check the status of the disease. If you start receiving other anti-cancer treatment, you will stop having these scans.

The study staff will also review your medical records and/or call you to check the status of the disease every 3 months after you stop receiving the study drugs. If you are called, it should take about 5 minutes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
Actual Study Start Date : April 2, 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: Gemcitabine + Cisplatin + Abraxane (Nab-Paclitaxel)

All 3 drugs administered intravenously on Day 1 and Day 8 of the cycle. Nab-Paclitaxel given at 100 mg/m2, followed by Cisplatin at 25 mg/m2 and then Gemcitabine at 800 mg/m2 for 2 weeks in a row followed by a week of rest. Cycles are 21 days.

Participant receives phone call from study staff 30 days after last dose of study drugs, and every 12 weeks thereafter.

Drug: Abraxane (Nab-Paclitaxel)
100 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
  • Nab-Paclitaxel
  • Paclitaxel (Protein-Bound)
  • ABI-007

Drug: Cisplatin
25 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

Drug: Gemcitabine
800 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar

Behavioral: Phone Calls
Participant receives phone call from study staff 30 days after last dose of study drugs, and every 12 weeks thereafter.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [ Time Frame: 63 days ]
    Response and progression evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1, 2009). The Bayes factor single arm time-to-event model by Johnson & Cook will be used to monitor the PFS time.


Secondary Outcome Measures :
  1. Response Rate (RR) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [ Time Frame: 63 days ]
    Response rate defined as partial response (PR), complete response (CR), and stable disease (SD). PR: At least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PR: At least a 30% decrease in sum of (LD) of target lesions taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not sufficient for diagnosis.
  2. Metastatic or unresectable disease documented on diagnostic imaging studies.
  3. May not have received prior chemotherapy. If patient has received prior adjuvant therapy, must be > 6 months from treatment.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  5. Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,500 cells/mm^3; b) Platelets =/>100,000/ul; c) Hemoglobin >9.0 g/dL; d) Total bilirubin =/<1.5mg/dL (In patients with known Gilbert's syndrome direct bilirubin =/<1.5 x ULN will be used as organ function criteria, instead of total bilirubin; e) AST and ALT =/< 5 x ULN; f) Creatinine =/<1.5 gm/dL
  6. Negative serum or urine pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy.
  7. A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom.
  8. Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.
  9. Patient is =/>18 years of age on the day of consenting to the study.

Exclusion Criteria:

  1. Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)"
  2. Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection.
  3. Pregnancy (positive pregnancy test) or lactation.
  4. Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392637


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene
Investigators
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Principal Investigator: Milind Javle, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02392637     History of Changes
Other Study ID Numbers: 2014-0524
NCI-2015-00578 ( Registry Identifier: NCI CTRP )
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Biliary Tract Cancer
Intrahepatic cholangiocarcinoma
Extrahepatic cholangiocarcinoma,
Gallbladder cancer
Metastatic
Unresectable
Abraxane
Nab-Paclitaxel
Paclitaxel (Protein-Bound)
ABI-007
Cisplatin
Platinol-AQ
Platinol
CDDP
Gemcitabine
Gemcitabine Hydrochloride
Gemzar
Phone calls
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs