DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077077

Purpose

RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, 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 DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: DJ-927 Drug: capecitabine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

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

Study Start Date:

February 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with locally advanced or metastatic solid tumors.
Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.

Secondary

Determine the toxicity profile of this regimen in these patients.
Determine the possible pharmacokinetic interactions of this regimen in these patients.
Determine the antitumor activity of this regimen in these patients.

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

Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14.
Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 2-15.
Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 1-14.

All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine 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. A minimum of 6 patients receive treatment at the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.

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 solid tumor
- Locally advanced or metastatic disease
Minimally pretreated
No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 3 months

Hematopoietic

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

Hepatic

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

Renal

Creatinine no greater than 1.5 times ULN

Gastrointestinal

No prior chronic diarrhea
No swallowing and/or malabsorption problems
No diarrhea (excess of 2-3 stools/day above normal frequency in the past month)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine
No concurrent serious infection
No neuropathy grade 2 or greater
No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other severe or uncontrolled underlying medical disease that would preclude study participation
No psychiatric disorder that would preclude giving informed consent or study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent anticancer biologic therapy

Chemotherapy

Recovered from prior chemotherapy
No other concurrent anticancer chemotherapy

Endocrine therapy

Not specified

Radiotherapy

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

Surgery

At least 4 weeks since prior major surgery and recovered
No prior major surgery in the stomach or small intestine

Other

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077077

Locations

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Investigator:

Chris H. Takimoto, MD, PhD, FACP

Cancer Therapy and Research Center, Texas

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000346368, DAIICHI-927A-PRT006, WSU-085503MP4F
Study First Received:	February 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00077077 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Neoplasms
Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009