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Status:

COMPLETED

Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progress...

Detailed Description

OBJECTIVES: Primary * Compare the benefits, in terms of progression-free survival, of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after firs...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria:
  • High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or clear cell disease
  • Stage II, III, or IV disease
  • Completed first-line therapy within the past 6 weeks
  • Received a platinum derivative (carboplatin or cisplatin) alone or in combination with other agents for 6-9 courses
  • Must have achieved complete response/no evidence of disease, partial response, or stabilization of disease after therapy
  • No adenocarcinoma of unknown origin
  • No known brain metastases or leptomeningeal disease
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 2,000/mm\^3
  • Hepatic
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with known liver metastases)
  • Bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases
  • PT and PTT ≤ 1.5 times ULN
  • Renal
  • Creatinine ≤ 2 times ULN
  • Cardiovascular
  • No myocardial infarction within past 6 months
  • No second- or third-degree heart block without pacemaker
  • Gastrointestinal
  • No active peptic ulcer disease
  • No gastrointestinal tract disease that would interfere with ability to take oral medications, affect absorption, or require parenteral nutrition
  • No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant dermatologic disease
  • No inflammatory changes to the surface of the eye
  • No history of allergic reaction to compounds of similar chemical composition as erlotinib
  • No other significant medical condition or neurologic or psychiatric disorder
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix
  • No psychiatric illness or familial, geographic, or social situation that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior therapy targeting epidermal growth factor receptor
  • No concurrent immunotherapy
  • Chemotherapy
  • See Disease Characteristics
  • See Surgery
  • No concurrent chemotherapy
  • Endocrine therapy
  • No concurrent hormonal therapy
  • Radiotherapy
  • No prior radiotherapy unless completed more than 5 years ago AND outside the abdomen/pelvis
  • Surgery
  • Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus
  • Other
  • No other prior or concurrent investigational agents
  • No other concurrent anticancer treatment
  • Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    835 Patients enrolled

    Trial Details

    Trial ID

    NCT00263822

    Start Date

    September 1 2005

    Last Update

    August 27 2013

    Active Locations (92)

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

    Page 1 of 23 (92 locations)

    1

    Prince of Wales Private Hospital

    Randwick, New South Wales, Australia, 2031

    2

    Tamworth Base Hospital

    Tamworth, New South Wales, Australia, 2340

    3

    Manning Base Hospital

    Taree, New South Wales, Australia, 2430

    4

    Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, Australia, 2298