MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors.

Study Overview

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors.
Assess the toxicity of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of MS-209.

Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course. On day 1 of the 2nd course, patients receive MS-209 orally followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 4-7 courses (including course with docetaxel alone). Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose limiting toxicities.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lille, France, 59020
    - Centre Oscar Lambret
  - Paris, France, 75248
    - Institut Curie - Section Medicale
Germany
- - Munich (Muenchen), Germany, D-80639
    - Haemato-Onkologische Praxis und Tagesklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically confirmed advanced malignant solid tumor
- No gastric cancer
No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 11.2 g/dL

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN

Renal:

Creatinine no greater than 1.4 mg/dL

Cardiovascular:

Normal cardiac function
Left ventricular ejection fraction normal

Other:

No digestive disease that hampers absorption
No unstable systemic disease or uncontrolled infection that precludes study
No psychological, familial, sociological, or geographical condition that precludes compliance
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior immunotherapy

Chemotherapy:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
No prior docetaxel
No other concurrent chemotherapy

Endocrine therapy:

At least 4 weeks since prior hormonal therapy

Radiotherapy:

At least 4 weeks since prior radiotherapy (6 weeks if extensive)

Surgery:

Not specified

Other:

No other concurrent anticancer drugs
No other concurrent investigational therapies
No H2-blockers, proton pump inhibitors, sucralfate or any other drug that would impair absorption
No concurrent drugs exhibiting liver, kidney, heart or lung toxicity
No concurrent MDR-modulating drugs (e.g., calcium antagonists, immunosuppressives)
No concurrent antifungals (ketoconazole, fluconazole) or antibiotics (clarithromycin, erthromycin) that interfere with MS-209 metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair: Veronique DIERAS, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

September 30, 2003

First Posted (Estimate)

October 1, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

unspecified adult solid tumor, protocol specific

Additional Relevant MeSH Terms

Other Study ID Numbers

EORTC-16992

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.