Study of Axitinib and Temsirolimus in Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | October 2011 |
| End Date: | October 2014 |
| Contact: | John Kauh, MD |
| Email: | jkauh@emory.edu |
| Phone: | 1-888-946-7447 |
Phase I Study of Axitinib and Temsirolimus in Solid Tumors
This study is being done to determine the highest safe dose of the combination of
temsirolimus and axitinib; to learn the side effects when these drugs are given together;
and to determine how the patient's disease responds to treatment.
The combination of the drugs temsirolimus and axitinib has not been studied before so it is
unknown whether this treatment will have any benefit in the patient's cancer.
Temsirolimus is commercially available and approved for treatment of some types of kidney
cancer.
Axitinib has been tested in several diseases but it is not yet commercially available for
the treatment of any cancer in the United States.
The combination of temsirolimus and axitinib is not approved for treatment of any cancer
outside of a clinical trial.
Inclusion Criteria/Exclusion Criteria:
- Patients must have histologically confirmed non-hematologic malignancy for which
standard curative or palliative measures do not exist or are no longer effective.
- Patients with hepatocellular carcinoma do not need histologic confirmation of
malignancy if the following criteria were met at diagnosis:
- Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of
CT/MRI
- Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of
CT/MRI or serum alpha-feto protein ≥ 200 ng/mL
- ECOG Performance Status 0 or 1
- Marrow and Organ function requirements:
- Absolute Neutrophil Count ≥ 1000/mm3
- Platelets ≥ 75,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)
- AST and ALT ≤2.5 x ULN (≤ 5 x ULN if liver metastasis present or patient has
diagnosis of hepatocellular carcinoma or cholangiocarcinoma)
- Creatinine ≤ 1.5 x ULN
- Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0
If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine
protein should be obtained and the level should be < 1000mg for patient
enrollment.
- Fasting serum cholesterol ≤ 350mg/dL
- Triglycerides ≤1.5 x ULN
- Life Expectancy ≥ 12 weeks
- At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab
containing regimens), radiotherapy, or surgical procedure with resolution of all
treatment related toxicity.
- No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90
measured 1 hour apart. Prexisting hypertension controlled with medication is
allowed.
- No gastrointestinal disorders including active peptic ulcer disease (within 6
months); active bleeding unrelated to malignancy; or melena, hematemesis, or
hematochezia in the past 3 months without endoscopically-proven resolution
- No cardiovascular history within 12 months including: MI, uncontrolled angina, CABG,
or symptomatic CHF
- Women of child bearing potential must have negative pregnancy test.
- Willingness and ability to comply with scheduled visits.
- Able to ingest oral medications
- No concurrent use or anticipated need for potent CYP3A4 inhibitors or CYP3A4 or
CYP1A2 inducers
We found this trial at
1
site
1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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