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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Paclitaxel

Carboplatin

Etoposide

About this trial

This is an interventional treatment trial for Neuroendocrine Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Overall response

Secondary Outcome Measures

Overall survival

Time to progression

Overall toxicity

Full Information

NCT ID

NCT00193531

First Posted

September 12, 2005

Last Updated

April 10, 2023

Sponsor

SCRI Development Innovations, LLC

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00193531

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 1998 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

Detailed Description

Upon determination of eligibility, patients will be receive: Paclitaxel + Carboplatin + Etoposide

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Type

Drug

Intervention Name(s)

Etoposide

Primary Outcome Measure Information:

Title

Overall response

Secondary Outcome Measure Information:

Title

Overall survival

Title

Time to progression

Title

Overall toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Hainsworth, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

16877720

Citation

Hainsworth JD, Spigel DR, Litchy S, Greco FA. Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. J Clin Oncol. 2006 Aug 1;24(22):3548-54. doi: 10.1200/JCO.2005.05.0575.

Results Reference

result

Neuroendocrine Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial