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Home > Patient Guide > Clinical Trials
Clinical Trials: Detail
| Title: | Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers |
| Trial Start Date: | |
| Trial End Date: | |
| Principal Investigator: | Robert Fine, MD |
| Description: | The primary goal is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers, including carcinoid tumors and excluding small cell cancer of lung or other origin (e.g. GI tract) which are poorly differentiated.
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| Criteria: | Inclusion Criteria
1. A tissue diagnosis of a metastatic neuroendocrine tumor, with progressive metastatic disease demonstrated by prior serial CT or MRI scans.
2. Patients must have failed prior or current high dose octreotide therapy (i.e. Sandostatin LAR-60 mg/month) and/or radioactive isotopes linked to octreotide or its congeners if they had a positive octreotide scan. (Patients with negative octreotide scans are not required to fail octreotide therapy)
3. Disease measurable by at least one diameter via CT or MRI scan.
4. Ineligible for other high priority national or institutional studies.
5. Prior radiation and surgery IS allowed if it has been longer than 3 weeks since either surgery, chemotherapy or hepatic emobilization/chemoembolization or radioactive isotopes and greater than 4 weeks since most recent radioactive treatment.
6. Age: between 18-80 years old, with a life expectancy > 3 months.
7. Men and women of childbearing potential must consent to using effective barrier contraception while on treatment and for 2 months thereafter.
Exclusion Criteria:
1. Prior chemotherapy with capecitabine or temozolomide or similar therapies (i.e. DTIC, or continuous infusion of 5-FU ). Acceptable prior therapies include bolus 5FU, streptozocin, anthracyclines, etoposide, or a platinum agent.
2. History of severe hypersensitivity reaction to either capecitabine, 5FU, temozolomide or DTIC.
3. Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
4. Patients with brain metastases.
5. Patients known to have HIV.
6. Prior history over the past 10 years of other cancers except basal cell cancer of the skin or cervical cancer in situ previously treated successfully. |
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| Clinical Areas: | Pancreas |
| Contact: | For more information, please contact
Joanna Martinez-Gomez,
Phone: 212-305-9337
E-mail: jm2648@columbia.edu
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CLINICAL TRIALS
You can play a more active role in your own health care, gain access to innovative therapies before they become widely available, and help others by contributing to advancements in medical research by participating in clinical trials.
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