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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
105
Start Date
August 2001
Primary Completion Date
April 2004
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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Andreas du Bois, MD, PhD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00031954
Organization ID
AGO-OVAR 8
Secondary IDs
AGOSG-OVAR-8
Responsible Party
Sponsor
Study Sponsor
AGO Study Group
Study Sponsor
Andreas du Bois, MD, PhD, Study Chair, Dr. Horst-Schmidt-Kliniken
Verification Date
December 2015