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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00031954
Other study ID # AGO-OVAR 8
Secondary ID AGOSG-OVAR-8EU-2
Status Completed
Phase Phase 2
First received March 8, 2002
Last updated December 22, 2015
Start date August 2001

Study information

Verified date December 2015
Source AGO Study Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
carboplatin

gemcitabine hydrochloride

paclitaxel


Locations

Country Name City State
Germany Universitaetsklinikum Charite Berlin
Germany Zentralkrankenhaus Bremen
Germany Medizinische Klinik I Dresden
Germany Evangelisches Krankenhaus Dusseldorf
Germany Klinikum der J.W. Goethe Universitaet Frankfurt
Germany Staedtisches Krankenhaus FFM-Hoechst Frankfurt Am Main
Germany Universitaetsklinik Goettingen Gottingen
Germany Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet Greifswald
Germany Frauenklinik der MHH Hannover
Germany Vincentius Krankenhaus Karlsruhe
Germany Christian-Albrechts University of Kiel Kiel
Germany Klinik der Otto-v.-Guericke-Universitat Magdeburg
Germany Klinik und Poliklinik fuer Kinderheilkunde Muenster
Germany Klinikum Grosshadern Munich (Muenchen)
Germany Klinikum Rechts Der Isar/Technische Universitaet Muenchen Munich (Muenchen)
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Universitaet Ulm Ulm
Germany Dr. Horst-Schmidt-Kliniken Wiesbaden

Sponsors (1)

Lead Sponsor Collaborator
AGO Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 pacl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Based on decision level Yes
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