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Status:

COMPLETED

PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

Lead Sponsor:

Proacta, Incorporated

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of PR-104 in combination with docetaxel or gemcitabine hydrochloride in patients with solid tumors. Secondary * Determine the safety of P...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed solid tumor malignancy
  • Treatment with either docetaxel or gemcitabine hydrochloride in combination with an investigational agent is reasonable
  • Measurable or evaluable disease
  • PATIENT CHARACTERISTICS:
  • ECOG performance status of 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed)
  • Bilirubin normal
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • PT/INR or aPTT ≤ 1.1 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study therapy
  • No evidence of any other significant medical disorder, including uncontrolled infection or infection requiring a concurrent parenteral antibiotic, or laboratory finding that, in the opinion of the investigator, would preclude study compliance
  • No known HIV positivity
  • No hepatitis B surface antigen positivity
  • No hepatitis C positivity with abnormal liver function test
  • PRIOR CONCURRENT THERAPY:
  • No prior radiotherapy to \> 25% of bone marrow
  • No prior high-dose chemotherapy (including conditioning for either myeloablative or nonmyeloablative transplantation)
  • No more than 3 prior chemotherapy regimens
  • More than 4 weeks since prior major surgery
  • More than 4 weeks since prior investigational or traditional anticancer therapy (including radiotherapy) (6 weeks for nitrosoureas and mitomycin C)
  • The following medications/treatments are not permitted during the trial:
  • Any other licensed or investigational anticancer treatment
  • Prophylactic hematopoietic growth factors
  • Irradiation therapy (palliative or therapeutic) unless given in the absence of tumor progression
  • Concurrent systemic steroids allowed provided the patient is on a stable dose for ≥ 2 weeks prior to study treatment
  • Concurrent androgen-deprivation therapy allowed

Exclusion

    Key Trial Info

    Start Date :

    February 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT00459836

    Start Date

    February 1 2007

    Last Update

    March 2 2011

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Proacta, Incorporated

    San Diego, California, United States, 92121

    2

    University of Auckland Cancer Center

    Auckland, New Zealand

    3

    Waikato Hospital

    Hamilton, New Zealand, 2020