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Status:

COMPLETED

Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lead Sponsor:

NHS Greater Glasgow and Clyde

Conditions:

Fallopian Tube Cancer

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This rand...

Detailed Description

OBJECTIVES: Primary * Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-esc...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer\*
  • Stage IC-IV disease
  • Peritoneal carcinomatosis\* (ovarian-type) must not be a mucin-secreting tumor
  • Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: \* Histologic confirmation of a primary source in the ovary is not required.
  • If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
  • Patient has a pelvis (ovarian) mass AND all of the following:
  • Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease
  • Serum CA 125/CEA ratio \> 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization
  • Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
  • Cytoreductive surgery may or may not have been successful during staging laparotomy
  • No mixed mesodermal tumors
  • No borderline ovarian tumors or tumors termed "possibly malignant"
  • No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
  • Considered unsuitable for or unwilling to receive platinum-taxane combination therapy
  • No concurrent endometrial cancer
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-3
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN
  • Renal
  • Creatinine clearance ≥ 30 mL/min
  • Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry
  • Cardiovascular
  • No hypertension
  • No ischemic heart disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No uncontrolled infection
  • No other severe and/or uncontrolled medical condition
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy
  • No other concurrent cytotoxic chemotherapy until progressive disease occurs
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy
  • Surgery
  • See Disease Characteristics

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 1 2010

    Estimated Enrollment :

    1300 Patients enrolled

    Trial Details

    Trial ID

    NCT00098878

    Start Date

    March 1 2004

    End Date

    July 1 2010

    Last Update

    August 7 2013

    Active Locations (88)

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

    Page 1 of 22 (88 locations)

    1

    Sydney Heamatology and Oncology Clinics

    Hornsby, New South Wales, Australia, 2077

    2

    Lismore Base Hospital

    Lismore, New South Wales, Australia, 2480

    3

    Institute of Oncology at Prince of Wales Hospital

    Randwick, New South Wales, Australia, 2031

    4

    Royal North Shore Hospital

    St Leonards, New South Wales, Australia, 2065