Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	DAIICHI-927A-PRT006 WSU-085503MP4F, NCT00077077

Objectives

Primary

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

Secondary

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

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed solid tumor
  • Locally advanced or metastatic disease



• Minimally pretreated



• No symptomatic brain metastases

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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Daiichi Sankyo, Incorporated

Chris Takimoto, MD, PhD, FACP, Study coordinator		Ph: 210-562-1725; 800-340-2872

Registry Information
Official Title		A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Trial Start Date		2004-02-06
Registered in ClinicalTrials.gov		NCT00077077
Date Submitted to PDQ		2003-11-13
Information Last Verified		2006-01-05

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