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Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on March 8, 2002.   Last Updated on April 19, 2011   History of Changes
Sponsor: AGO 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
Primary Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase II

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

Resource links provided by NLM:


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00031954     History of Changes
Other Study ID Numbers: CDR0000069242, AGOSG-OVAR-8, EU-20146
Study First Received: March 8, 2002
Last Updated: April 19, 2011
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
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012