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Status:

COMPLETED

Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

Lead Sponsor:

Fred Hutchinson Cancer Center

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed s...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
  • Stage III or IV disease
  • The following histologic epithelial cell types are allowed:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mixed epithelial carcinoma
  • Undifferentiated carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner tumor
  • Adenocarcinoma not otherwise specified
  • Must have undergone appropriate surgery for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer within the past 6 weeks
  • No borderline ovarian tumor of low malignant potential
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin normal
  • Meets 1 of the following criteria:
  • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST or ALT normal
  • No hepatic disease that would preclude study participation
  • Renal
  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance \> 50 mL/min
  • No renal disease that would preclude study participation
  • Cardiovascular
  • LVEF ≥ lower limit of normal\*
  • No poorly controlled arrhythmia
  • No unstable coronary artery disease
  • No myocardial infarction within the past year NOTE: \*LVEF evaluation performed only on patients requiring it
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No peripheral neuropathy ≥ grade 2
  • No other nonmalignant systemic disease that would preclude study participation
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No medical, social, or psychosocial factor that would preclude study participation
  • No psychiatric or addictive disorder that would preclude giving informed consent
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior immunotherapy for this malignancy
  • Chemotherapy
  • No prior chemotherapy for this malignancy
  • Endocrine therapy
  • No prior hormonal therapy for this malignancy
  • Radiotherapy
  • No prior radiotherapy for this malignancy
  • Surgery
  • See Disease Characteristics
  • No planned interval cytoreductive surgery
  • Second-look surgery allowed
  • Other
  • More than 1 year since prior experimental or investigational therapy
  • No concurrent therapeutic anticoagulation with warfarin

Exclusion

    Key Trial Info

    Start Date :

    June 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00217529

    Start Date

    June 1 2004

    Last Update

    September 21 2010

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    Pacific Gynecology Specialists

    Seattle, Washington, United States, 98104

    2

    Fred Hutchinson Cancer Research Center

    Seattle, Washington, United States, 98109-1024

    3

    University of Washington School of Medicine

    Seattle, Washington, United States, 98195