Phase 2
N=85
Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Gastric Adenocarcinoma · Gastroesophageal Adenocarcinoma · Distal Esophageal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01757171 ↗Enrolled (actual)
85
Serious AEs
55.3%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants With Progression at the 3 Month Follow up Visit — 15; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabazitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression at the 3 Month Follow up Visit |
15; 7 | — |
| SECONDARY Duration of Event Free Survival of Subjects Treated With Cabazitaxel |
2.17; 1.31 | — |
| SECONDARY Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes |
12; 5; 5; 3; 1; 0 | — |
| SECONDARY Percent of Participants Treated With Cabazitaxel With Event Free Survival |
11.32; 13 | — |
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
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* 45/cc (using Cockroft-Gault formula)
- 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 /= 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.
Data sourced from ClinicalTrials.gov (NCT01757171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.