Gastric Adenocarcinoma Clinical Trial
Official title:
An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Verified date | March 2018 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 85 |
Est. completion date | June 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Yale University | New Haven | Connecticut |
United States | Weill Cornell Medical College | New York | New York |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months | |
Secondary | 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 | 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 | |
Secondary | 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 | 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 | |
Secondary | Percent of Participants Treated With Cabazitaxel With Event Free Survival | To examine other measures of efficacy such as overall survival in all evaluable patients | 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 |
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