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OpenTrials
Completed

NCT Number: NCT00193531

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

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.

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Key information

Conditions

Neuroendocrine Carcinoma Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Upon determination of eligibility, patients will be receive:

  • Paclitaxel + Carboplatin + Etoposide

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paclitaxel

Drug

carboplatin

Drug

etoposide

Drug

Primary outcomes

  1. Overall response

Secondary outcomes

  1. Overall survival

  2. Time to progression

  3. Overall toxicity

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Phase II Study of Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma

Important dates

Study start
1998
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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