Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer
The purpose of this study is to find out what effects, good and/or bad, the combination of the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine, radiation, and the study drug kill cancer cells in different ways. Giving these treatments together may make your cancer shrink or slow down its growth more than it would if you got treated with capecitabine and radiation alone.
This is a Phase I drug study of ganetespib given together with capecitabine and radiation in patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not approved by the Food and Drug Administration (FDA). The other two, capecitabine and radiation, are approved by FDA for use in rectal cancer.
In this study, the investigators will test different dosages of the "investigational" (experimental) drug, called ganetespib (the study drug). The study drug is "investigational" because it is not approved by the FDA for use. The study drug has been previously tested in humans. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. In addition, the study will help researchers to determine what the side effects and drug interactions might be.
The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and capecitabine with radiation work in your body (for example how long the drugs last in your body.)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer|
- Tumor response and disease progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2016|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: capecitabine + ganetespib .
Capecitabine oral medication. Ganetespib IV medication
Drug: capecitabine + ganetespib
Capecitabine will be started on Day 1 of the concurrent chemo-radiation phase at the specified dose, and is given orally twice daily for the entire duration of radiation therapy.
Ganetespib will be started on Day 1 of radiation therapy and is administered as IV infusion over 1 hour on days 1, 8, 15 for cycle 1 and then on days 29 and 36 for cycle 2.
In all patients, ganetespib monotherapy will be given up to 2 weeks prior to start of concurrent chemoradiation. Sequential biopsies will be taken at baseline and prior to the start of concurrent chemoradiation. In the dose escalation part of the study, the starting does of ganetespib is 60mg/m² once weekly, and capecitabine at a dose of 825 mg/m² twice daily.
Patients with rectal cancer who meet the eligibility criteria will be offered to enroll on the study. As part of the study patients will receive the standard of care capecitabine (825 mg/m² by mouth twice daily) and radiation. Patients will start on ganetespib (STA9090) at a set dose level.
The treatment consists of two parts. In the first part patients will receive ganetespib at full dose twice a week through the vein for two weeks. At the end of two weeks, a biopsy of the tumor will be performed to evaluate the effect of the drug on the tumor. In the second phase, patients will receive capecitabine, radiation and ganetespib at a specified dose level for 5 to 6 weeks. After completion of this phase, patients will have surgery to remove the tumor. Each three patients will be treated at a specified dose level. Patients will be monitored at least once a week for side effects. If there are no side effects in three consecutive patients, then the investigators will treat the next three patients at a higher dose level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554969
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University|