The United States National Institute of Health recruits candidates to participate in clinical trials aimed at better diagnosis and treatment of neuroendocrine tumor disease. The following links provide lists of trials concerned with neuroendocrine tumors and also carcinoid disease.
The European Neuroendocrine Tumor Society is involved in ongoing clinical trials that concentrate on the therapeutic options in treating tumors of the foregut, midgut and hindgut.
Foregut ENET-1 Study
The ENET-1 Study is an open, prospective, randomized European multicenter study in patients with neuroendocrine tumors of the pancreas and bronchial tract. The study compares biotherapy (Sandostatin LAR 30 mg) with chemotherapy (Streptozotocin/5-FU). The calculated number of patients to be included is 160; treatment duration is 12 months. Inclusion criteria are:
- well-differentiated neuroendocrine histology (according to Ki67 Index),
- inoperability or metastasized disease,
- demonstrated tumor progression within the last three months and,
- non-active tumor of the foregut (bronchial, pancreatic, stomach, duodenal up to the Treitz ligamentum)
Further inclusion-criteria are:
- a two-dimensionally measurable reference lesion (CT/MRT),
- no earlier medical therapy with either Sandostatin (patients with prior therapy up to a maximum of three months of SSA can be included) or chemotherapy,
- Age 18 - 75 years and
- Karnofsky Index > 60.
Exclusion criteria are:
- hypersecretion syndrome,
- poorly differentiated or small-cell neuroendocrine carcinoma,
- secondary malignancy,
- severe kidney or liver disease
- decompensated heart failure.
The primary endpoint is the rate of objective tumor response. The secondary endpoint includes time to progression, biochemical responses, quality of life/Karnofsky-Index, toxicity and survival.
The procedure is as follows: Sandostatin LAR 30 mg every 28 days or Streptozotocin (STZ) 500 mg/m2 i.v for 5 days and 5-FU 400 mg/m2 i.v. for five days, to be repeated after d43, with cross-over at progression.
Statistics are as follows: Equivalence study, with a maximum of 20% difference. 80 patients per arm, power of 80% (alpha = 0.05).
Current status is as follows: Start of study: February 2001. Status as of June 2007: 31 Patients.
Contact:
Studiensekretariat Neuroendokrine Tumore
Prof. Dr. Bertram Wiedenmann
Med. Klinik m.S. Hepatologie und Gastroenterologie
Charite - Campus Virchow Klinikum, Universitätsmedizin Berlin
Augustenburger Platz 1, 13353 Berlin, Germany
Tel.: +49 30 450 553 032
Fax.: +49 30 450 553 970
E-mail: 
or
PD Dr. Marianne Pavel
Tel: + 49 30 450 653 304
E-mail: 
Midgut PROMID
This study is a prospective, double-blind, randomized, placebo-controlled, multicenter study on the antiproliferative effects of Octreotide in patients with metastasized neuroendocrine midgut tumors (PROMID). The study considers the antiproliferative effects of Sandostatin LAR on unresectable, well-differentiated midgut tumors.
Its design is as follows: Sandostatin LAR 30 mg vs. placebo; double blind, multicentered and national. The duration is 18 months, 162 patients should be included.
Inclusion criteria are:
- Well-differentiated neuroendocrine carcinoma, according to histology,
- inoperable or metastasized tumor,
- functionally active or inactive tumor and
- two-dimensionally measurable lesions (CT/MRT).
Further requirements:
- therapy-naïve patients with regard to Sandostatin (max. 3 months therapy),
- age 18 -75 years,
- Karnofsky Index > 60.
Exclusion criteria include:
- poorly differentiated or small cell neuroendocrine carcinoma,
- pre-treatment with alpha-interferon, chemotherapy or chemo-embolization,
- secondary malignancy,
- liver insufficiency or
- decompensated heart failure.
The primary endpoint is time to progression; the secondary endpoint includes objective response rate, biochemical response, quality of life, control of symptoms and survival.
The procedure is as follows: Medication every 28 days; imaging every 3 months; Start of study: July 2001. Status, as of April 2007: 80 Patients.
Contact:
KKS-Marburg
Tel:+49 6421 2866528
E-mail: 
PTK/ZK Angiogenesis inhibitor in NET
The issue to be considered is the effectiveness and optimal dosage of PTK/ZK in patients with metastasized neuroendocrine carcinoma. The design is as follows: A prospective, international, multicenter phase II study. The duration of the study is 12 months and the calculated number of patients is 54. The total duration is three years.
Inclusion criteria:
- metastasized neuroendocrine carcinoma,
- Ki67 18 years.
Exclusion criteria include:
- Presence of brain metastases
- Any severe/uncontrolled medical conditions such as: uncontrolled diabetes mellitus, liver diseases, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≠6month, uncontrolled cardiac arrhythmias, congenital QT-syndrome, poorly controlled hypertension, chronic renal disease, acute or chronic liver diseases, active uncontrolled infection.
- Other prior or concurrent malignancy within the last 5 years.
- Coumadine medication or medication metabolized by cytochrome p450
- Impaired bone marrow function (ANC 1.5xUNL, total urine protein > 500mg/d and creatinin clearance >50 mg/dl
- AST/ALT> 3xUNL, serum bilirubin >1,5 mg/dl.
The primary endpoint is time to progression. The secondary endpoints are response rate, biochemical response, survival time, quality of life, body weight, and toxicity.
The procedure is as follows: Dosage: 1250 mg/d. Controls at weeks 2, 4, 8, 13, 26, 39, and 52 (Clinic, Laboratory); Imaging every three months. Optional: Biopsy (Ki67, micro vessel density) before and after Tx. Start September 2005. Status at June 2007: 26 Patients.
Contact:
(Germany)
Studiensekretariat Neuroendokrine Tumore
Prof. Dr. Bertram Wiedenmann,
Med. Klinik m.S. Hepatologie und Gastroenterologie
Charite - Campus Virchow Klinikum, Universitätsmedizin Berlin, Germany
Augustenburger Platz 1, 13353 Berlin,
Tel.: +49 30 450 553 032
Fax.: +49 30 450 553 970
E-mail: 
or
PD Dr. Marianne Pavel
Tel: + 49 30 450 653 304
E-mail: 
(United Kingdom)
Prof. William Steward
Dept. of Oncology
University of Leicester
Leicester Royal Infirmary,
LE1 5WW
Phone: + 44 (0) 116 258 7597
Fax: +44 (0) 116 258 7599
ADMINISTRATIVE OFFICE: ENETS Office, Campus Virchow-Klinikum
Augustenburger Platz 1
13353 Berlin, Germany
Tel: +49 (30) 450-553096
Fax: +49 (30) 450-553942
email: 