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Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: AGO Ovarian Cancer Study Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031954
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

Drug Information available for:   Carboplatin    Gemcitabine hydrochloride    Gemcitabine    Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2001

Detailed Description:

OBJECTIVES:

  • Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
  • Determine the response rate of patients treated with this regimen.
  • Determine the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma

    • No tumors of low-malignant potential (borderline tumors)
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months

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
  • Hemoglobin greater than 10 g/dL

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal

Renal:

  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
  • No myocardial infarction within the past 6 months
  • No history of atrial or ventricular arrhythmias

Neurologic:

  • No history of seizure disorder
  • No history of CNS disorder
  • No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

Other:

  • No severe concurrent infection
  • No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
  • No complete bowel obstruction
  • No other concurrent severe medical problems that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent WBC transfusions

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except replacement therapy or steroid antiemetics

Radiotherapy:

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • No more than 6 weeks since prior definitive surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031954

Locations
Germany
Christian-Albrechts University of Kiel    
      Kiel, Germany, D-24105
Dr. Horst-Schmidt-Kliniken    
      Wiesbaden, Germany, D-65199
Evangelisches Krankenhaus    
      Dusseldorf, Germany, DOH-4-0217
Frauenklinik der MHH    
      Hannover, Germany, 30659
Klinik der Otto-v.-Guericke-Universitat    
      Magdeburg, Germany, 39108
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet    
      Greifswald, Germany, D-17487
Klinik und Poliklinik fuer Kinderheilkunde    
      Muenster, Germany, D-48129
Klinikum der J.W. Goethe Universitaet    
      Frankfurt, Germany, D-60590
Klinikum Grosshadern    
      Munich (Muenchen), Germany, D-81377
Zentralkrankenhaus    
      Bremen, Germany, D-28205
Medizinische Klinik I    
      Dresden, Germany, D-01307
Staedtisches Krankenhaus FFM-Hoechst    
      Frankfurt Am Main, Germany, 65929
Universitaet Ulm    
      Ulm, Germany, D-89075
Universitaetsklinik Goettingen    
      Gottingen, Germany, D-37075
Universitaetsklinikum Charite    
      Berlin, Germany, D-10117
Universitaetsklinikum Tuebingen    
      Tuebingen, Germany, D-72076
Vincentius Krankenhaus    
      Karlsruhe, Germany, D-76137
Klinikum Rechts Der Isar/Technische Universitaet Muenchen    
      Munich (Muenchen), Germany, D-81675

Sponsors and Collaborators
AGO Ovarian Cancer Study Group

Investigators
Study Chair:     Andreas du Bois, MD, PhD     Dr. Horst-Schmidt-Kliniken    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069242, AGOSG-OVAR-8, EU-20146
First Received:   March 8, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00031954
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer  
stage I ovarian epithelial cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Ovarian epithelial cancer
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Fallopian tube cancer
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2008




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