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

NCT ID: NCT00031954

Last Updated: 2015-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AGO Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas du Bois, MD, PhD

Role: STUDY_CHAIR

Dr. Horst-Schmidt-Kliniken

Locations

Universitaetsklinikum Charite

Berlin, , Germany

Zentralkrankenhaus

Bremen, , Germany

Medizinische Klinik I

Dresden, , Germany

Evangelisches Krankenhaus

Düsseldorf, , Germany

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Staedtisches Krankenhaus FFM-Hoechst

Frankfurt am Main, , Germany

Universitaetsklinik Goettingen

Göttingen, , Germany

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, , Germany

Frauenklinik der MHH

Hanover, , Germany

Vincentius Krankenhaus

Karlsruhe, , Germany

Christian-Albrechts University of Kiel

Kiel, , Germany

Klinik der Otto-v.-Guericke-Universitat

Magdeburg, , Germany

Klinikum Grosshadern

Munich (Muenchen), , Germany

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich (Muenchen), , Germany

Klinik und Poliklinik fuer Kinderheilkunde

Münster, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Universitaet Ulm

Ulm, , Germany

Dr. Horst-Schmidt-Kliniken

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 15661234 (View on PubMed)

Other Identifiers

AGOSG-OVAR-8

Identifier Type: -

Identifier Source: secondary_id

EU-20146

Identifier Type: -

Identifier Source: secondary_id

AGO-OVAR 8

Identifier Type: -

Identifier Source: org_study_id