A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001426|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : April 5, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasm||Drug: Cyclophosphamide Drug: Paclitaxel Drug: Cisplatin Drug: G-CSF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Official Title:||A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer|
|Study Start Date :||February 3, 1995|
|Actual Primary Completion Date :||October 15, 2007|
|Actual Study Completion Date :||November 7, 2013|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA:
All patients must have biopsy proven, newly diagnosed epithelial ovarian cancer, primary epithelial fallopian tube cancer, or peritoneal surface carcinoma. Histopathologic diagnosis must be confirmed in the pathology department of the treating institution prior to initiation of therapy. Diagnosis will be confirmed in the Laboratory of Pathology, National Cancer Institute. This confirmation is not necessary prior to entering the patient onto protocol.
Patients must have FIGO stage III or IV disease and will undergo attempted surgical debulking prior to the initiation of chemotherapy.
Patients must be able to begin therapy within 6 weeks of staging laparotomy and should have an indwelling venous access device placed. A double lumen catheter is preferred.
Performance status of less than or equal to ECOG 2.
Patients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.
All patients must be registered by calling the Orkand Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST; Eligibility criteria will be queried.
Evidence CNS involvement (patients with normal clinical exam will not require a head CT scan or MRI).
History of myocardial infarction or unstable dysrhythmia within 1 month of study entry.
Creatinine clearance of less than 60 cc/min, ANC less than 1000/cm3, platelet count less than 1000,000/cm3.
History of active GI bleeding within the last 30 days.
Prior therapy other than surgery for this malignancy.
Abnormal PT, PTT, and bilirubin. SGOT greater than or equal to 3 times the upper limit of normal.
Previous history of invasive malignancy.
Patients with ureteral obstruction must have this corrected prior to starting therapy.
Patients with germ cell, mixed Muellerian and borderline histologies are specifically excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001426
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Elise C Kohn, M.D.||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||November 4, 1999 Key Record Dates|
|Last Update Posted:||April 5, 2018|
|Last Verified:||November 7, 2013|
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating