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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: February 10, 2004
Last updated: May 15, 2012
Last verified: May 2012

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 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: February 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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.


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


  • Histologically or cytologically confirmed solid tumor

    • Locally advanced or metastatic disease
  • Minimally pretreated
  • No symptomatic brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


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


  • 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


  • Creatinine no greater than 1.5 times ULN


  • 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)


  • 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


Biologic therapy

  • No concurrent anticancer biologic therapy


  • Recovered from prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified


  • 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


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


  • 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 identifier: NCT00077077

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

Additional Information:
Responsible Party: Daiichi Sankyo Inc. Identifier: NCT00077077     History of Changes
Other Study ID Numbers: CDR0000346368, DAIICHI-927A-PRT006, WSU-085503MP4F
Study First Received: February 10, 2004
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 17, 2014