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Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in High Grade Neuroendocrine Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193531
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 29, 2010
Bristol-Myers Squibb
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Drug: Paclitaxel Drug: Carboplatin Drug: Etoposide Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Paclitaxel + Carboplatin + Etoposide

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma
Study Start Date : December 1998
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. Overall response

Secondary Outcome Measures :
  1. Overall survival
  2. Time to progression
  3. Overall toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic poorly differentiated neuroendocrine carcinoma
  • Unknown primary site
  • Able to perform activities of daily living with minimal assistance
  • Measurable or evaluable disease
  • Adequate bone marrow, liver functions and kidney function
  • No previous treatment with chemotherapy
  • Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • Previous malignancy within five years
  • Women pregnant or lactating
  • Recent history of cardiovascular disease
  • Meningeal metastases

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193531

Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00193531     History of Changes
Other Study ID Numbers: SCRI MISC 16
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: October 2008

Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Albumin-Bound Paclitaxel
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors