Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00602082

First received: January 25, 2008

Last updated: July 15, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2008

Last Updated Date

July 15, 2009

Start Date ^ICMJE

August 2005

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00602082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall response rate
Functional response
Toxicity
Progression-free survival
Overall survival
Molecular markers predictive of response to chemotherapy
Quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors

Official Title ^ICMJE

A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.

PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.

Detailed Description

OBJECTIVES:

Primary

To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.

Secondary

To determine the overall response rate, including both objective and biochemical responses, to these regimens.
To determine the functional response to these regimens.
To determine the toxicity of these regimens.
To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
To determine the progression-free and overall survival of patients receiving these regimens.
To determine the quality of life of these patients.
To determine molecular markers predictive of response to chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to site of origin (known vs unknown primary site), prior antitumor treatment, tumor function (functional vs nonfunctional), and study center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive streptozocin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-21.
Arm II: Patients receive cisplatin IV over 2 hours on day 1 and streptozocin and capecitabine as in arm I.

In both treatment arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete the EORTC QLQC30 questionnaire and EORTC QLQ-GI.NET21 module for quality-of-life assessment at baseline, every 9 weeks during treatment, and at 12 weeks post-treatment.

Tumor tissue is obtained at baseline and assessed for Ki67 and mitotic index. Novel tissue-specific transcription factors (e.g., CDX2) are also assessed. Blood samples are collected at baseline and 9 weeks and examined by DNA, RNA, and proteomic analysis.

After completion of study therapy, patients are followed every 12 weeks.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Gastrointestinal Carcinoid Tumor
Islet Cell Tumor

Intervention ^ICMJE

Drug: capecitabine
Drug: cisplatin
Drug: streptozocin
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: protein analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed unresectable, advanced, and/or metastatic disease meeting one of the following types:
- Gastroentero-neuroendocrine tumor of the foregut
- Pancreatic neuroendocrine tumor
- Neuroendocrine tumor of unknown primary
Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (the longest diameter) ≥ 20 mm by conventional CT scanning or ≥ 10 mm by spiral CT scan or MRI
No bronchial neuroendocrine tumors (NETs) or other NETs where the primary site is situated in organs above the diaphragm (e.g., laryngeal and pharyngeal NETs)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 12 weeks
Hemoglobin ≥ 10 g/dL
Platelet count ≥ 100,000/mm³
WBC ≥ 3,000/mm³
ANC ≥ 1,500/mm³
Bilirubin ≤ 2 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times ULN
AST and ALT ≤ 5 times ULN
GFR ≥ 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
No other serious or uncontrolled illness that would preclude study participation
No medical or psychiatric condition that would influence the ability to provide consent

PRIOR CONCURRENT THERAPY:

At least 3 weeks since prior interferon therapy
No prior systemic chemotherapy or chemotherapy administered as part of a chemo-embolization regimen, or for this condition
No receptor-targeted radiolabeled therapy within the past 6 months
No investigational agent within the past 4 weeks
Prior and concurrent somatostatin analogues allowed provided symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to 6 months apart
No palliative radiotherapy involving lesions used to measure disease
- Palliative radiotherapy to regions not involved in measurement of disease allowed
No other concurrent chemotherapy for this condition

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00602082

Other Study ID Numbers ^ICMJE

CDR0000582315, CRCA-CCTC-NET-01, EUDRACT-2004-005202-71, EU-207102, ISRCTN35124268

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cambridge University Hospitals NHS Foundation Trust

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Investigator:	Pippa Corrie, PhD, FRCP	Cambridge University Hospitals NHS Foundation Trust
Investigator:	Tim Meyer, MD, BSc, MRCP, PhD	University College London (UCL) Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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