Capecitabine and Temozolomide for Neuroendocrine Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00869050
First received: March 23, 2009
Last updated: June 22, 2016
Last verified: June 2016
  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.

Condition Intervention Phase
Neuroendocrine Tumors
Drug: Capecitabine
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: 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:
  • Number of Participants With Partial Response (PR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.

  • Number of Participants With Complete Response (CR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.


Enrollment: 41
Study Start Date: August 2005
Study Completion Date: October 2014
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

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg 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 Name: Xeloda
Drug: Temozolomide

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 Name: Temodar

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  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 computerized tomography (CT) or magnetic resonance imaging (MRI) scans, or have increased symptoms from their tumors while on sandostatin LAR or octreotide.
  • Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree
  • Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas)
  • Pheochromocytomas, gastrinomas (Zollinger-Ellison Syndrome), multiple endocrine neoplasia (MEN) Type I/II, paragangliomas, adrenal carcinomas with NET markers by immunohistochemistry (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 Response Evaluation Criteria In Solid Tumors (RECIST) parameters by CT scan or MRI scan.
  • 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 radiation therapy (RT)
  • Non pregnant females, not in menopause, who are not breast feeding with a negative serum β-HCG (human chorionic gonadotropin) 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 (dacarbazine), 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, Camptothecin-11 (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: Paul E Oberstein, MD Columbia University
  More Information

Additional Information:
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00869050     History of Changes
Other Study ID Numbers: AAAP4117 
Study First Received: March 23, 2009
Results First Received: May 3, 2016
Last Updated: June 22, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Capecitabine
Temozolomide
Dacarbazine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 25, 2016