Status:
COMPLETED
STA-9090 in Previously Treated Patients With Advanced Esophagogastric Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Esophagogastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this research study, the investigators are looking to see how effective STA-9090 is in treating esophagogastric cancer. The investigators will also evaluate the side effects of STA-9090, and examin...
Detailed Description
* Each treatment cycle lasts 4 weeks during which time the study drug will be administered for three consecutive weeks followed by 1 week of no study drug. STA-9090 will be given by intravenous infusi...
Eligibility Criteria
Inclusion
- Participants must have histologically or cytologically confirmed advanced esophageal, gastroesophageal, or gastric cancer. When possible, archived biopsy or resection specimens must be available for correlative SNaPshot and FISH studies.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan (per RECIST criteria).
- Participants must have progressed through prior 1st-line therapy. For the purposes of this trial, neoadjuvant chemoradiation or peri-operative chemotherapy may be considered as prior 1st-line treatment in the event of metastatic recurrence.
- 18 years of age or older
- Life expectancy of greater than 12 weeks
- ECOG Performance status of 1 or greater
- Participants must have normal organ and marrow function as defined in the protocol.
- Participants must have adequate peripheral IV access. Administration of STA-9090 via indwelling catheters is prohibited at this time.
- No concurrent active primary or metastatic cancer other than superficial squamous cell or basal cell skin cancer.
- At least 3 weeks or 5 half-lives must have elapsed between the most recent dose of any prior anticancer therapy and the start date of treatment with STA-9090. Participants must have resolution to baseline of all toxicities associated with prior anticancer therapies.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion
- Participants may not be receiving any other standard or investigational anticancer agents, with the exception of hormonal therapy.
- Participants with known CNS metastases must have received whole-brain radiation or other appropriate therapy not less than 4 weeks prior to starting the study drug and exhibit clinical stability of brain disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STA-9090 or to the excipients PEG 300 and Polysorbate 80.
- Ventricular ejection fraction of 55% or less at baseline.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study. Breastfeeding should be discontinued
- HIV-positive individuals on combination antiretroviral therapy are ineligible.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01167114
Start Date
August 1 2010
End Date
April 1 2017
Last Update
November 2 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115