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

Primary Purpose

Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Distal Esophageal Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cabazitaxel

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
Subject must have evaluable disease as per RECIST criteria.
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
Age >/=18 years old.
ECOG performance status status >/= 2
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:

Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
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.
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
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.
Subject may not receive another investigational agent.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
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.

Sites / Locations

UCSF Comprehensive Cancer Center
Yale University
Dana Farber Cancer Institute
Karmanos Cancer Institute
Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A (taxane naïve)

Arm B (prior taxane therapy)

Arm Description

No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Outcomes

Primary Outcome Measures

Number of Participants With Progression at the 3 Month Follow up Visit

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

Duration of Event Free Survival of Subjects Treated With Cabazitaxel

To examine other measures of efficacy such as overall progression free in all evaluable patients

Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes

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

Percent of Participants Treated With Cabazitaxel With Event Free Survival

To examine other measures of efficacy such as overall survival in all evaluable patients

Full Information

NCT ID

NCT01757171

First Posted

December 6, 2012

Last Updated

March 7, 2018

Sponsor

Weill Medical College of Cornell University

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01757171

Brief Title

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

Official Title

An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Distal Esophageal Adenocarcinoma

Keywords

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (taxane naïve)

Arm Type

Experimental

Arm Description

No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Arm Title

Arm B (prior taxane therapy)

Arm Type

Experimental

Arm Description

Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Cabazitaxel

Intervention Description

20mg IV over 1 hour every 3 weeks

Primary Outcome Measure Information:

Title

Number of Participants With Progression at the 3 Month Follow up Visit

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Duration of Event Free Survival of Subjects Treated With Cabazitaxel

Description

To examine other measures of efficacy such as overall progression free in all evaluable patients

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

Title

Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes

Description

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

Title

Percent of Participants Treated With Cabazitaxel With Event Free Survival

Description

To examine other measures of efficacy such as overall survival in all evaluable patients

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma. Subject must have unresectable or metastatic gastroesophageal adenocarcinoma. Subject must have evaluable disease as per RECIST criteria. Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed. Age >/=18 years old. ECOG performance status status >/= 2 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: Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma. Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma. 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. 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 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. Subject may not receive another investigational agent. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manish Shah, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSF Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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