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Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01757171
Recruitment Status : Completed
First Posted : December 28, 2012
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy.

At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes


Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Gastroesophageal Adenocarcinoma Distal Esophageal Adenocarcinoma Drug: Cabazitaxel Phase 2

Detailed Description:

Prior to initiating protocol therapy, patients will undergo screening evaluations, to be done within 30 days of protocol initiation unless otherwise noted.

Patients who are taxane naïve will be assigned to arm A and patients who have had prior taxane therapy will be assigned to Arm B. Each arm will be analyzed separately for the primary study endpoint of 3 month progression free survival rate (PFS), as defined as the time from the start of treatment to the date of disease progression or death. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks.

In the absence of treatment delays due to adverse event(s), treatment may continue until disease progression; intercurrent illness that prevents further administration of treatment; unacceptable adverse event(s); patient decides to withdraw; general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Patients will be followed for 6 months after removal from study or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Actual Study Start Date : December 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A (taxane naïve)
No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks
Drug: Cabazitaxel
20mg IV over 1 hour every 3 weeks
Experimental: Arm B (prior taxane therapy)
Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks
Drug: Cabazitaxel
20mg IV over 1 hour every 3 weeks



Primary Outcome Measures :
  1. Number of Participants With Progression at the 3 Month Follow up Visit [ Time Frame: 3 months ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit


Secondary Outcome Measures :
  1. Duration of Event Free Survival of Subjects Treated With Cabazitaxel [ Time Frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    To examine other measures of efficacy such as overall progression free in all evaluable patients

  2. Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes [ Time Frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  3. Percent of Participants Treated With Cabazitaxel With Event Free Survival [ Time Frame: From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    To examine other measures of efficacy such as overall survival in all evaluable patients



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

Inclusion Criteria:

  1. Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
  2. Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
  3. Subject must have evaluable disease as per RECIST criteria.
  4. Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
  5. Age >/=18 years old.
  6. ECOG performance status status >/= 2
  7. Subject must have normal organ and marrow function as defined below:

    • WBC >/= 3,000/uL
    • Total Bilirubin ≤ 1.5 x upper limits of normal
    • AST (SGOT) ≤ 2.5 x upper limits of normal
    • ALT (SGPT) ≤ 2.5 x upper limits of normal
    • Hgb > 7.5 g/dl (without transfusion within 7 days)
    • ANC > 1000 /ml
    • Plt > 75 K/ml (without transfusion)
    • Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)

9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
  2. Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
  3. Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.
  4. Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:

    a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement

  5. Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms >/= grade 2 due to agents administered more than 4 weeks earlier.
  6. Subject may not receive another investigational agent.
  7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
  8. Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

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): NCT01757171


Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Sanofi
Investigators
Principal Investigator: Manish Shah, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01757171     History of Changes
Other Study ID Numbers: 1208012946
First Posted: December 28, 2012    Key Record Dates
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
Gastric Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Taxane
Antineoplastic Agents