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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV

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. 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

Related Conditions & MeSH terms

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

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