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

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
 Biological: filgrastim
Drug: cisplatin
Drug: cyclophosphamide
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
 Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A PHASE II STUDY OF CYCLOPHOSPHAMIDE, PACLITAXEL, CISPLATIN WITH G-CSF FOR PATIENTS WITH NEWLY DIAGNOSED ADVANCED STAGE OVARIAN CANCER

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cyclophosphamide Cisplatin Paclitaxel Filgrastim
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 80
Study Start Date: February 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019045

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elise C. Kohn, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Hussain MM, Seiden MV, Fuller A, et al.: A two institution phase II study of paclitaxel (T), cyclophosphamide (C), cisplatin (P) with G-CSF (G) for patients with newly diagnosed advanced stage ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-813, 2002.

Study ID Numbers: CDR0000064075, NCI-95-C-0055, NCI-CPB-349, NCI-T94-0162N
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00019045     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Genital Diseases, Female
Cisplatin
Peritoneal Diseases
Ovarian Cancer
Alkylating Agents
Endocrine Gland Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
 Adjuvants, Immunologic
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Ovarian Epithelial Cancer
Immunosuppressive Agents
Fallopian Tube Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Alkylating
Peritoneal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Alkylating Agents
Endocrine Gland Neoplasms
 Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Immunosuppressive Agents
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 04, 2009



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