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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00077077

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: DJ-927 Drug: capecitabine	Phase 1

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
3	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Daiichi Sankyo, Inc.

Investigators

: Chris H. Takimoto, MD, PhD, FACP, Cancer Therapy and Research Center, Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daiichi Sankyo, Inc.

ClinicalTrials.gov Identifier:

NCT00077077

Other Study ID Numbers:

CDR0000346368
DAIICHI-927A-PRT006
WSU-085503MP4F

First Posted:

Feb 11, 2004

Last Update Posted:

May 16, 2012

Last Verified:

May 1, 2012

Keywords provided by Daiichi Sankyo, Inc.

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms

Capecitabine

Study Results

No Results Posted as of May 16, 2012