Midostaurin (PKC412) for Locally Advanced Rectal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | August 2011 |
| End Date: | December 2018 |
Phase I Study of Chemoradiation With Midostaurin (PKC412) For Locally Advanced Rectal Cancer
This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call
5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of
kinase inhibitor which works by blocking proteins associated with cancer cell growth.
Previous studies also suggest that midostaurin may help increase the effectiveness of
radiation therapy. In this research we are looking for the highest dose of midostaurin that
can be given safely in combination with standard chemoradiation.
5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of
kinase inhibitor which works by blocking proteins associated with cancer cell growth.
Previous studies also suggest that midostaurin may help increase the effectiveness of
radiation therapy. In this research we are looking for the highest dose of midostaurin that
can be given safely in combination with standard chemoradiation.
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.
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
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