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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Carcinoma

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Trial Information

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


Upon determination of eligibility, patients will be receive:

- Paclitaxel + Carboplatin + Etoposide


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI MISC 16

NCT ID:

NCT00193531

Start Date:

December 1998

Completion Date:

January 2007

Related Keywords:

  • Neuroendocrine Carcinoma
  • Carcinoma
  • Carcinoma, Neuroendocrine

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