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

NCT00602082 | Completed Phase 2

• 5 other identifiers: CRCA-CCTC-NET-01CDR0000582315EUDRACT-2004-005202-71EU-207102ISRCTN35124268
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 17

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.

Conditions

Gastrointestinal Carcinoid Tumor; Islet Cell Tumor

Keywords

pancreatic alpha cell adenoma; pancreatic alpha cell carcinoma; pancreatic beta islet cell adenoma; pancreatic beta islet cell carcinoma; pancreatic delta cell adenoma; pancreatic delta cell carcinoma; pancreatic G-cell adenoma; pancreatic G-cell carcinoma; gastrinoma; insulinoma; glucagonoma; pancreatic polypeptide tumor; somatostatinoma; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; islet cell carcinoma; recurrent islet cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

Secondary Outcomes (7)

• Overall response rate

• Functional response

• Toxicity

• Progression-free survival

• Overall survival

Interventions

capecitabine DRUG

cisplatin DRUG

streptozocin DRUG

DNA analysis GENETIC

RNA analysis GENETIC

protein analysis GENETIC

proteomic profiling GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (17)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

UCL Cancer Institute

London, England, NW3 2QG, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

MeSH Terms

Conditions

Adenoma, Islet Cell; Gastrinoma; Insulinoma; Glucagonoma; Somatostatinoma; Carcinoma, Islet Cell

Interventions

Capecitabine; Cisplatin; Streptozocin

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Pippa Corrie, PhD, FRCP

  Cambridge University Hospitals NHS Foundation Trust

• Tim Meyer, MD, BSc, MRCP, PhD

  University College London (UCL) Cancer Institute

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: January 28, 2008
• Study Start: August 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 7, 2013

Record last verified: 2009-06

Locations

GB (17)