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

Phase 2
18 Years
Open (Enrolling)
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor

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Trial Information

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



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


- 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

- 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

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.

Inclusion Criteria


- 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)


- 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


- 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

- No other concurrent chemotherapy for this condition

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Principal Investigator

Pippa Corrie, PhD, FRCP

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust



Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • 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
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Adenoma, Islet Cell