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Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bortezomib
carboplatin
paclitaxel
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites: Esophagus Gastroesophageal junction Gastric cardia No greater than 2 cm from the gastroesophageal junction into the stomach Unresectable, metastatic disease Not a candidate for potentially curative therapy AND no other more reasonable potentially curative conventional therapy exists At least 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan No known CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN Renal Creatinine ≤ 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No uncontrolled infection No chronic debilitating disease No prior allergic reaction to carboplatin or paclitaxel No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for recurrent or metastatic disease No prior biologic therapy for recurrent or metastatic disease No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy No prior chemotherapy for recurrent or metastatic disease Prior chemotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed Prior combination chemotherapy and radiotherapy allowed provided patient achieved a complete response AND the last dose of combination therapy was administered ≥ 6 months ago Endocrine therapy Not specified Radiotherapy See Chemotherapy No prior radiotherapy for recurrent or metastatic disease Prior radiotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed No prior radiotherapy to > 25% of bone marrow for locally advanced disease More than 4 weeks since prior radiotherapy Surgery More than 4 weeks since prior open abdominal exploration (e.g., laparotomy) More than 2 weeks since prior minimally invasive procedures (e.g., laparoscopy)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    bortezomib + paclitaxel + carboplatin

    Arm Description

    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

    Outcomes

    Primary Outcome Measures

    Confirmed tumor response rate

    Secondary Outcome Measures

    Time to tumor progression
    Overall survival
    Duration of response

    Full Information

    First Posted
    April 5, 2005
    Last Updated
    December 9, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00107341
    Brief Title
    Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction
    Official Title
    A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for Metastatic Adenocarcinoma of the Lower Esophagus, Gastroesophageal Junction, and Gastric Cardia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with unresectable, metastatic cancer of the esophagus or gastroesophageal junction.
    Detailed Description
    OBJECTIVES: Primary Determine the confirmed tumor response rate in patients with unresectable, metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with bortezomib, paclitaxel, and carboplatin. Secondary Determine the time to tumor progression, overall survival, and duration of response in patients treated with this regimen. Determine the adverse events in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 17 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Cancer
    Keywords
    adenocarcinoma of the esophagus, stage IV esophageal cancer, recurrent esophageal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bortezomib + paclitaxel + carboplatin
    Arm Type
    Experimental
    Arm Description
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.
    Intervention Type
    Drug
    Intervention Name(s)
    bortezomib
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel
    Primary Outcome Measure Information:
    Title
    Confirmed tumor response rate
    Time Frame
    Up to 3 years
    Secondary Outcome Measure Information:
    Title
    Time to tumor progression
    Time Frame
    Up to 3 years
    Title
    Overall survival
    Time Frame
    Up to 3 years
    Title
    Duration of response
    Time Frame
    Up to 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites: Esophagus Gastroesophageal junction Gastric cardia No greater than 2 cm from the gastroesophageal junction into the stomach Unresectable, metastatic disease Not a candidate for potentially curative therapy AND no other more reasonable potentially curative conventional therapy exists At least 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan No known CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN Renal Creatinine ≤ 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No uncontrolled infection No chronic debilitating disease No prior allergic reaction to carboplatin or paclitaxel No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for recurrent or metastatic disease No prior biologic therapy for recurrent or metastatic disease No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy No prior chemotherapy for recurrent or metastatic disease Prior chemotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed Prior combination chemotherapy and radiotherapy allowed provided patient achieved a complete response AND the last dose of combination therapy was administered ≥ 6 months ago Endocrine therapy Not specified Radiotherapy See Chemotherapy No prior radiotherapy for recurrent or metastatic disease Prior radiotherapy in the neoadjuvant or adjuvant setting (after complete resection of the original tumor) allowed No prior radiotherapy to > 25% of bone marrow for locally advanced disease More than 4 weeks since prior radiotherapy Surgery More than 4 weeks since prior open abdominal exploration (e.g., laparotomy) More than 2 weeks since prior minimally invasive procedures (e.g., laparoscopy)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aminah Jatoi, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20126980
    Citation
    Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.
    Results Reference
    background
    PubMed Identifier
    18449005
    Citation
    Jatoi A, Dakhil SR, Foster NR, Ma C, Rowland KM Jr, Moore DF Jr, Jaslowski AJ, Thomas SP, Hauge MD, Flynn PJ, Stella PJ, Alberts SR. Bortezomib, paclitaxel, and carboplatin as a first-line regimen for patients with metastatic esophageal, gastric, and gastroesophageal cancer: phase II results from the North Central Cancer Treatment Group (N044B). J Thorac Oncol. 2008 May;3(5):516-20. doi: 10.1097/JTO.0b013e31816de276.
    Results Reference
    result

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    Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction

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