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Status:

COMPLETED

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

Lead Sponsor:

Daiichi Sankyo

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 tum...

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-limitin...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    January 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00077077

    Start Date

    February 1 2004

    End Date

    January 1 2006

    Last Update

    May 16 2012

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    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