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Combination Chemotherapy in Treating Patients With Ovarian Cancer
This study is ongoing, but not recruiting participants.
Study NCT00019045   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
February 1995
 
 
 
Complete list of historical versions of study NCT00019045 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Ovarian Cancer
A PHASE II STUDY OF CYCLOPHOSPHAMIDE, PACLITAXEL, CISPLATIN WITH G-CSF FOR PATIENTS WITH NEWLY DIAGNOSED ADVANCED STAGE OVARIAN CANCER

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 consisting of cisplatin, cyclophosphamide, and paclitaxel plus filgrastim in treating patients with newly-diagnosed and resected stage III ovarian cancer or stage IV ovarian epithelial cancer.

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed, debulked stage III/IV ovarian epithelial cancer treated with dose-intensive paclitaxel/cisplatin/cyclophosphamide with filgrastim (G-CSF).
  • Characterize the toxic effects of this regimen in these patients.
  • Analyze molecular markers of DNA damage repair and genetic risk in ovarian cancer tissue samples, with cytogenetic assessment performed where available.
  • Correlate molecular marker results with response to therapy, tumor type, and survival.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV over 15 minutes followed immediately by paclitaxel IV over 24 hours on day 1. Cisplatin IV over 1 hour is administered on day 2 for 6 courses only. Filgrastim (G-CSF) is administered subcutaneously on days 3-11. Treatment repeats every 21 days for at least 6 courses.

Patients who achieve a complete response proceed to laparoscopy or second look laparotomy, then receive 2 more courses of chemotherapy. Patients with partial response or stable disease continue to receive cyclophosphamide and paclitaxel, with restaging every 2 courses. Patients with bulky residual disease proceed to interim debulking surgery after 8 courses of chemotherapy.

Patients are followed every 3 months for 3 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

Phase II
Interventional
Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Procedure: neoadjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
 
 

DISEASE CHARACTERISTICS:

  • Histologically proven, newly diagnosed, ovarian epithelial cancer, primary epithelial fallopian tube cancer, or primary peritoneal carcinoma
  • Stage III or IV disease
  • No CNS involvement
  • Surgical debulking attempted prior to chemotherapy
  • No germ cell tumors
  • No mixed Muellerian or borderline tumors

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • PT and PTT normal

Renal:

  • Creatinine clearance at least 60 mL/min
  • Correction of ureteral obstruction required prior to therapy

Cardiovascular:

  • No history of myocardial infarction or unstable dysrhythmia within 1 month

Other:

  • No history of active gastrointestinal bleeding within 30 days
  • No history of invasive malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this malignancy

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • No prior endocrine therapy for this malignancy

Radiotherapy

  • No prior radiotherapy for this malignancy

Surgery

  • Prior surgery for this malignancy allowed
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019045
 
CDR0000064075, NCI-95-C-0055, NCI-CPB-349, NCI-T94-0162N
National Cancer Institute (NCI)
 
Principal Investigator: Elise C. Kohn, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP