search
Back to results

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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
AGO Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaetsklinikum Charite
  • Zentralkrankenhaus
  • Medizinische Klinik I
  • Evangelisches Krankenhaus
  • Staedtisches Krankenhaus FFM-Hoechst
  • Klinikum der J.W. Goethe Universitaet
  • Universitaetsklinik Goettingen
  • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Frauenklinik der MHH
  • Vincentius Krankenhaus
  • Christian-Albrechts University of Kiel
  • Klinik der Otto-v.-Guericke-Universitat
  • Klinik und Poliklinik fuer Kinderheilkunde
  • Klinikum Grosshadern
  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen
  • Universitaetsklinikum Tuebingen
  • Universitaet Ulm
  • Dr. Horst-Schmidt-Kliniken

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
December 22, 2015
Sponsor
AGO Study Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00031954
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGO Study Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
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
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas du Bois, MD, PhD
Organizational Affiliation
Dr. Horst-Schmidt-Kliniken
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsklinikum Charite
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Zentralkrankenhaus
City
Bremen
ZIP/Postal Code
D-28205
Country
Germany
Facility Name
Medizinische Klinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Dusseldorf
ZIP/Postal Code
DOH-4-0217
Country
Germany
Facility Name
Staedtisches Krankenhaus FFM-Hoechst
City
Frankfurt Am Main
ZIP/Postal Code
65929
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Universitaetsklinik Goettingen
City
Gottingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17487
Country
Germany
Facility Name
Frauenklinik der MHH
City
Hannover
ZIP/Postal Code
30659
Country
Germany
Facility Name
Vincentius Krankenhaus
City
Karlsruhe
ZIP/Postal Code
D-76137
Country
Germany
Facility Name
Christian-Albrechts University of Kiel
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Klinik der Otto-v.-Guericke-Universitat
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Klinik und Poliklinik fuer Kinderheilkunde
City
Muenster
ZIP/Postal Code
D-48129
Country
Germany
Facility Name
Klinikum Grosshadern
City
Munich (Muenchen)
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
City
Munich (Muenchen)
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15661234
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs