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Status:

COMPLETED

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking th...

Detailed Description

OBJECTIVES: Primary * Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive adva...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Progressive, persistent, or recurrent disease
  • Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
  • Tumor lesions accessible for biopsy
  • Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
  • No more than 2 prior chemotherapy regimens
  • At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2 OR
  • Karnofsky 60-100%
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hepatic
  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN
  • Renal
  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 50 mL/min
  • Cardiovascular
  • No history of coronary artery disease
  • No symptomatic cardiac dysfunction
  • No cardiac pathology by electrocardiogram\* NOTE: \*Patients with symptomatic coronary artery disease must undergo an electrocardiogram
  • Pulmonary
  • No symptomatic pulmonary dysfunction
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 8 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
  • No insulin-dependent diabetes mellitus
  • Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior biologic therapy and recovered
  • Chemotherapy
  • See Disease Characterisitcs
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior topotecan
  • No other prior topoisomerase I inhibitors
  • Endocrine therapy
  • More than 4 weeks since prior hormonal therapy and recovered
  • Radiotherapy
  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 40% of bone marrow
  • No prior mediastinal irradiation
  • Surgery
  • More than 4 weeks since prior surgery and recovered
  • Other
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00072267

    Start Date

    January 1 2004

    Last Update

    July 23 2015

    Active Locations (4)

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

    Page 1 of 1 (4 locations)

    1

    Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, Canada, L8V 5C2

    2

    Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, Canada, N6A 4L6

    3

    Ottawa Regional Cancer Centre

    Ottawa, Ontario, Canada, K1H 8L6

    4

    Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9