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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193531
First received: September 12, 2005
Last updated: June 28, 2010
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Neuroendocrine Carcinoma
 Drug: Paclitaxel
Drug: Carboplatin
Drug: Etoposide
 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 Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Overall response

Secondary Outcome Measures:
  • Overall survival
  • Time to progression
  • Overall toxicity

Estimated Enrollment: 100
Study Start Date: December 1998
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Paclitaxel + Carboplatin + Etoposide
  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193531

Sponsors and Collaborators
Sarah Cannon Research Institute
Bristol-Myers Squibb
Investigators
Principal Investigator: John D. Hainsworth, MD Sarah Cannon Research Institute
  More Information

Additional Information:
Published article in the Journal of Clinical Oncology  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00193531     History of Changes
Other Study ID Numbers: SCRI MISC 16
Study First Received: September 12, 2005
Last Updated: June 28, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Etoposide
 Paclitaxel
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013