Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
18 Years
N/A
Both
Adenocarcinoma of the Rectum
Trial Information
Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
Midostaurin capsules will be taken by mouth for 8 weeks. For the first 2 weeks midostaurin
will be taken alone (no chemoradiation). After 2 weeks standard chemoradiation will be
added to the midostaurin regimen. Subjects receive midostaurin and chemoradiation for an
additional 6 weeks. Physical exams will be done weekly. Blood samples will be taken and an
optional tumor biopsy will be performed in week 2.
4-5 weeks after completing chemoradiation and midostaurin subjects will undergo surgery as
standard of care. Tumor tissue from the surgery will be used for research purposes. A Ct
scan of chest, abdomen, and pelvis will be performed.
After completion of surgery, subjects will have an end of study visit with physical exam,
blood tests. CT scans of chest, abdomen, and pelvis will be performed yearly for 5 years.
Inclusion Criteria:
- Adenocarcinoma of the rectum
- T3/4 or N+ disease
- Life expectancy > 3 months
- Normal organ and marrow function
Exclusion Criteria:
- Metastatic disease
- Pregnant or breastfeeding
- Prior radiotherapy
- Receiving other investigational agents
- History of inflammatory bowel disease
- Active scleroderma or CREST syndrome
- Uncontrolled intercurrent illness
- History of a different malignancy unless disease free for at least 5 years
- HIV or active viral hepatitis
- Impaired cardiac function
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine Maximum Tolerated Dose (MTD) of midostaurin in combination with standard 5-FU chemoradiation
Outcome Time Frame:
1.5 years
Safety Issue:
Yes
Principal Investigator
Theodore S Hong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
10-457
NCT ID:
NCT01282502
Start Date:
August 2011
Completion Date:
Related Keywords:
- Adenocarcinoma of the Rectum
- rectal cancer
- chemotherapy
- chemoradiation
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Rectal Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
