An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
18 Years
N/A
Both
Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Distal Esophageal Adenocarcinoma
Trial Information
An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
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 25 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to cabazitaxel
Outcome Description:
To demonstrate the antitumor activity as assessed by the rate of progression free survival at three months of the sanofi-aventis product cabazitaxel 25mg/m2 IV over 1 hour every 3 weeks in subjects with previously treated metastatic gastroesophageal adenocarcinoma who are either taxane naïve, or taxane previously treated.
Outcome Time Frame:
estimation of 4 years to determine response on all subjects
Safety Issue:
No
Principal Investigator
Manish Shah, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Food and Drug Administration
Study ID:
1208012946
NCT ID:
NCT01757171
Start Date:
December 2012
Completion Date:
December 2016
Related Keywords:
- Gastric Adenocarcinoma
- Gastroesophageal Adenocarcinoma
- Distal Esophageal Adenocarcinoma
- Gastric Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
- Stomach Neoplasms
Name | Location |
|---|---|
| Weill Cornell Medical College | New York, New York 10021 |
