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CompletedNCT00031954Updated Dec 23, 2015

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

A Phase 2 interventional study of carboplatin and gemcitabine hydrochloride in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by AGO Study Group. Completed at 18 sites in Germany. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-12-23.

Sponsored by AGO Study Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer

Keywords

  • 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
03

In context

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's enrollment of 105 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

AGO Study Group is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Interventions

  • Drugcarboplatin
  • Druggemcitabine hydrochloride
  • Drugpaclitaxel
06

What researchers measure

Primary outcomes

  1. Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity

    The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05

    Time frame: Based on decision level

07

Study locations

18 sites
  • Universitaetsklinikum Charite
    Berlin, D-10117, Germany
  • Zentralkrankenhaus
    Bremen, D-28205, Germany
  • Medizinische Klinik I
    Dresden, D-01307, Germany
  • Evangelisches Krankenhaus
    Dusseldorf, DOH-4-0217, Germany
  • Staedtisches Krankenhaus FFM-Hoechst
    Frankfurt Am Main, 65929, Germany
  • Klinikum der J.W. Goethe Universitaet
    Frankfurt, D-60590, Germany
  • Universitaetsklinik Goettingen
    Gottingen, D-37075, Germany
  • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
    Greifswald, D-17487, Germany
  • Frauenklinik der MHH
    Hannover, 30659, Germany
  • Vincentius Krankenhaus
    Karlsruhe, D-76137, Germany
  • Christian-Albrechts University of Kiel
    Kiel, D-24105, Germany
  • Klinik der Otto-v.-Guericke-Universitat
    Magdeburg, 39108, Germany
  • Klinik und Poliklinik fuer Kinderheilkunde
    Muenster, D-48129, Germany
  • Klinikum Grosshadern
    Munich (Muenchen), D-81377, Germany
  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
    Munich (Muenchen), D-81675, Germany
  • Universitaetsklinikum Tuebingen
    Tuebingen, D-72076, Germany
  • Universitaet Ulm
    Ulm, D-89075, Germany
  • Dr. Horst-Schmidt-Kliniken
    Wiesbaden, D-65199, Germany
08

References and documents

Publications

  • du Bois A, Belau A, Wagner U, Pfisterer J, Schmalfeldt B, Richter B, Staehle A, Jackisch C, Lueck HJ, Schroeder W, Burges A, Olbricht S, Elser G; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR). A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol. 2005 Feb;96(2):444-51. doi: 10.1016/j.ygyno.2004.10.020. PubMed 15661234 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00031954
Lead sponsor
AGO Study Group
Responsible party
Sponsor
First posted
Jul 1, 2003
Start date
Aug 2001
Primary completion
Apr 2004
Last update
Dec 23, 2015

Study contacts

Andreas du Bois, MD, PhD
study chair · Dr. Horst-Schmidt-Kliniken
View the source record on ClinicalTrials.gov ↗

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