Clinical trial NCT00031954: Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Official title: A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: AGO Study Group
Sponsor class: OTHER
First posted: 2003-07-01
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: Based on decision level
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite
city: Bremen
country: Germany
facility: Zentralkrankenhaus
city: Dresden
country: Germany
facility: Medizinische Klinik I
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Frankfurt Am Main
country: Germany
facility: Staedtisches Krankenhaus FFM-Hoechst
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universitaet
city: Gottingen
country: Germany
facility: Universitaetsklinik Goettingen
city: Greifswald
country: Germany
facility: Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
city: Hannover
country: Germany
facility: Frauenklinik der MHH
city: Karlsruhe
country: Germany
facility: Vincentius Krankenhaus
city: Kiel
country: Germany
facility: Christian-Albrechts University of Kiel
city: Magdeburg
country: Germany
facility: Klinik der Otto-v.-Guericke-Universitat
city: Muenster
country: Germany
facility: Klinik und Poliklinik fuer Kinderheilkunde
city: Munich (Muenchen)
country: Germany
facility: Klinikum Grosshadern
city: Munich (Muenchen)
country: Germany
facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitaet Ulm
city: Wiesbaden
country: Germany
facility: Dr. Horst-Schmidt-Kliniken
Study officials:
affiliation: Dr. Horst-Schmidt-Kliniken
name: Andreas du Bois, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.