MDACC Study Summary 2008-0483

Study Summary
No. 2008-0483:.......Gastrointestinal; Pancreas......Alexandria T. Phan......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2008-0483

Study Title:	PHASE III, RANDOMISED, DOUBLE BLIND, STRATIFIED COMPARATIVE, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE STUDY TO ASSESS THE EFFECT OF DEEP SUBCUTANEOUS INJECTIONS OF LANREOTIDE AUTOGEL 120 MG ADMINISTERED EVERY 28 DAYS ON TUMOUR PROGRESSION FREE SURVIVAL IN PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR (2-55-52030-726)

Physician

New Patient Referral



Name:	Alexandria T. Phan	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal Pancreas	Supported By:	Ipsen Research and Development

Phase of Study:	Phase III	Return Visit:	Every 28 days (ą1 day) in order to receive the study drug injection.

Treatment Agents:	Lanreotide autogel	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to learn if and how long lanreotide autogel may be able to stop endocrine tumors from growing. Lanreotide autogel will be compared to a placebo (a substance that looks like the study drug but has no active ingredients). The safety of lanreotide autogel will also be studied.

Study Objectives / Outcomes

Primary Study Objective
The primary study objective is to assess the effect of lanreotide Autogel 120 mg administered every 28 days compared to placebo, on progression-free survival in patients with well or moderately differentiated non functioning entero-pancreatic endocrine tumours.

The primary endpoint will be time to either disease progression [measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria] or death, occurring within 96 weeks after first treatment administration.

Secondary Study Objectives

To compare the proportion of patients alive and without progression between both groups at 48 and 96 weeks,
To compare time to progression in patients with progression between both groups,
To assess the overall survival in this patient population,
To assess the effect of lanreotide Autogel 120 mg compared to placebo on quality of life using EORTC QLQ-C30 and QLQ-GI.NET21,
To assess the effect of lanreotide Autogel 120 mg compared to placebo on plasma chromogranin A and on any other tumour peptide markers with elevated level at baseline (Visit 2),
To assess the clinical and biological safety profile of lanreotide Autogel 120 mg,
To assess the putative appearance of anti-lanreotide antibodies,
To assess the pharmacokinetic profile of lanreotide Autogel 120 mg.

Study Status Information



Study Activation / Registration Date:	12/01/2008

IRB Review and Approval Date:	12/01/2008

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	200

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Has provided written informed consent prior to any study-related procedures

2) Is a male or a female of 18 years of age or older

3) Has an endocrine tumour confirmed by centrally assessed histological criteria

4) Has metastatic disease and/or locally advanced inoperable tumour, or the patient has refused surgery (documented)

5) Has a tumour measurable according to RECIST criteria (central assessment)

6) Has no hormone related symptoms

7) Has a non functioning entero-pancreatic tumour of unknown origin; or with a known primary localisation in the pancreas, mid-gut, or hindgut, or a gastrinoma adequately controlled by proton-pump inhibitors (4 months stable prior to study entry)

8) Has a well or moderately differentiated tumour (central assessment)

9) Has a tumour with a proliferation index (Ki67) <10% or, in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index </=2 mitosis/10HPF (central assessment)

10) Has a >/= grade 2 octreoscan assessed using the Krenning scale, during the screening period or within 6 months prior to study entry (Visit 1) for the organ of target lesions

11) Has a World Health Organisation (WHO) performance score lower or equal to 2

12) Has had a biopsy performed within 6 months prior to the screening visit if the patient has had a previous cancer or, if in the opinion of the investigator, there is evidence of clinical progression

Exclusion Criteria:

1) Has been treated with a somatostatin analogue at any time prior to study entry (Visit 1), except if that treatment was for less than 15 days (e.g. peri-operatively) and the treatment was received more than 6 months before study entry (Visit 1)

2) Has been treated with radionuclide at any time prior to study entry (Visit 1)

3) Has been treated with interferon, chemobolisation or chemotherapy within 6 months prior to study entry (Visit 1)

4) Has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for more than 5 years)

5) Has a history of hypersensitivity to drugs with a similar chemical structure such as somatostatin

6) Has been treated with any other unlicensed drug within the last 30 days before study entry (Visit 1)

7) Is likely to require treatment during the study with drugs that are not permitted by the study protocol such as: interferon, radionuclide (other than that used for octreoscan), chemotherapy or chemoembolisation; any somatostatin analogues other than study drug; GH (growth hormone) antagonist; and cyclosporin

8) Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test at study entry (Visit 1) and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation or hysterectomy at least 3 months before the start of the study

9) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude

10) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study

11) Has been previously enrolled in this study

12) Has had major surgery related to the studied disease within 3 months prior to entering the study

13) Has a multiple endocrine neoplasia (MEN)

Links

Registration Number: NCT00353496
Study Information on Clinical Trials Registry (clinicaltrials.gov)