Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors - Full Text View

Sponsored by:	Daiichi Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072228

Purpose

RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, 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: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: gemcitabine Drug: soblidotin Procedure: chemotherapy	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine TZT 1027

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

Primary

Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.
Determine the dose-limiting toxic effects of this regimen in these patients.

Secondary

Determine the toxicity profile of this regimen in these patients.
Determine the pharmacokinetics of this regimen in these patients.
Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for survival every 3 months after completion of study therapy.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed locally advanced or metastatic solid tumors
Minimally pretreated
Not refractory to prior gemcitabine therapy
No disease progression during initial treatment with gemcitabine
No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 12 weeks

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

Ejection fraction at least 40% by MUGA

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric disorder that would preclude study consent or compliance
No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome
No hypersensitivity to gemcitabine
No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years
No serious infection
No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent anticancer biologic therapy

Chemotherapy

See Disease Characteristics
Recovered from prior chemotherapy
No other concurrent anticancer chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Recovered from prior radiotherapy
No concurrent anticancer radiotherapy
Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective

Surgery

At least 4 weeks since prior major surgery and recovered

Other

More than 28 days since prior investigational drugs, including analgesics or antiemetics
At least 4 weeks since prior myelosuppressive therapy
No other concurrent anticancer therapy
No other concurrent anticancer cytotoxic therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072228

Locations

United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Daiichi Pharmaceuticals

Investigators

Study Chair:

Robert L. DeJager, MD, FACP

Daiichi Pharmaceuticals

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000339345, DAIICHI-1027A-PRT008, CPMC-IRB-20031085, NCT00072228
Study First Received:	November 4, 2003
Last Updated:	December 4, 2006
ClinicalTrials.gov Identifier:	NCT00072228
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Gemcitabine
Soblidotin

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009