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

Neuroendocrine Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193531
• Other study ID #: SCRI MISC 16
• Status: Completed
• Phase: Phase 2
• Start date: December 1998
• Est. completion date: January 2007

Study information

• Verified date: April 2023
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, patients will be receive:

• Paclitaxel + Carboplatin + Etoposide

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma

Intervention

Drug:
• Paclitaxel

• Carboplatin

• Etoposide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bristol-Myers Squibb

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response
Secondary	Overall survival
Secondary	Time to progression
Secondary	Overall toxicity