Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01757171
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-071
Cabazitaxel will be administered 25 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
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Peter Enzinger, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960
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
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.
1. Subject with previously untreated unresectable or metastatic gastroesophageal
2. Subject with more than 2 prior cytotoxic therapies (not including treatment
administered for locally curable disease) for unresectable or metastatic
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
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
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