Capecitabine and Temozolomide for Neuroendocrine Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Robert L. Fine, Columbia University
ClinicalTrials.gov Identifier:
NCT00869050
First received: March 23, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This phase II study is designed to assess whether treatment with capecitabine/temozolomide ('CAP/TEM') is safe and effective in treating subjects with progressive, differentiated, metastatic neuroendocrine tumors (NET).The primary objective of the study is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers. Secondary objectives include determining the overall and one year survival rates to this regimen, to determine progression free survival, to assess toxicities, improvement of quality of life, biochemical responses of tumor markers, and relief from NET symptoms.


Condition Intervention Phase
Neuroendocrine Tumors
Drug: Capecitabine and temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Time to response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: August 2005
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine and Temozolomide
Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Drug: Capecitabine and temozolomide

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Temozolomide 150-200 mg/m2/day (PO divided BID) Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles

After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

Other Names:
  • Xeloda
  • Temodar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a tissue diagnosis of any of the following metastatic, well or moderately differentiated, slow growing neuroendocrine tumor and must demonstrate progressive metastatic disease by prior serial CT or MRI scans, or have increased symptoms from their tumors while on sandostatin LAR or octreotide.
  • Carcinoid tumors originating anywhere in the body including the GI tract or bronchial tree
  • Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas)
  • Pheochromocytomas, gastrinomas (Zollinger-Ellison Syndrome), MEN Type I/II, paraganaliomas, adrenal carcinomas with NET markers by IHC or serum.
  • Somatostatinoma, VIPoma, Merkel Cell tumors, medullary thyroid carcinoma
  • Neuroendocrine tumors of unknown primary site
  • Any other tumors with differentiated neuroendocrine features may be included such as aggressive pituitary adenomas/carcinomas, which are neuroendocrine in origin
  • Patients must have progressed on octreotide therapy (up to and including Sandostatin LAR-60 mg/month) and/or radioactive isotopes linked to octreotide or its congeners if they has a positive octreotide scan. Patients who have negative or mildly positive octreotide scans are exempt from this requirement. Exceptions to this requirement are patients who have NETs in the pituitary gland. Sandostatin does not cross into the pituitary blood supply well.
  • Measurable disease: Any primary and/or metastatic mass reproducibly measurable in one or two diameters by RECIST parameters by CT scan or MRI scan. PET or octreotide scans are useful adjuncts but will not be used to measure response Exceptions to RECIST: In the case of tumors of the head and neck, the criteria for response is not RECIST, we will follow standard criteria for head & neck tumors as suggested by ASCO 2009 guidelines. In the case of small lung lesions that are symptomatic, but do not meet RECIST, we will evaluate response by analyzing respiratory signs and symptoms (there is no other beneficial treatment available for these lesions)
  • Ineligible for other high priority national or institutional studies
  • Prior radiation and surgery allowed: ≥3 weeks since surgery or chemotherapy or hepatic embolization/chemoembolization or radioactive isotopes (i.e. Yttrium 90)

    ≥4 weeks since RT

  • Non pregnant females, not in menopause, who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must consent to using effective barrier contraception while on treatment and for 2 months thereafter.

Exclusion Criteria:

  • Prior chemotherapy with capecitabine or temozolomide. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded. Patients can have had prior therapies up to 3 prior chemotherapy regimens such as bolus 5-FU, streptozocin, anthracyclines, CPT-11, etoposide, or a platinum agent
  • Hypersensitivity: Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide or DTIC will be excluded (i.e. anaphylaxis or anaphylactoid reactions)
  • Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g, serious infection)
  • Patients with tumor which has spread to the central brain (cerebral/cerebellum) and spinal cord.
  • Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study
  • Prior malignancies in the last 5 years other than; curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past year)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869050

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Robert L Fine, MD Columbia University
  More Information

No publications provided

Responsible Party: Robert L. Fine, Associate Professor of Medicine at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00869050     History of Changes
Other Study ID Numbers: AAAB3348
Study First Received: March 23, 2009
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
MEN Type I/II
Pancreatic cancer
Neuroendocrine tumors
Carcinoid tumors
Pheochromocytomas
Gastrinomas
Zollinger-Ellison syndrome
Somatostatinomas
VIPomas
Merkel cell tumors
modullary thyroid carcinoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Capecitabine
Fluorouracil
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014