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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00077077
First received: February 10, 2004
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  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 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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:

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

Publications:

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov 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:
Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013