A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT00001426
• Recruitment Status: Completed
• First Posted: November 4, 1999
• Last Update Posted: April 5, 2018
• Sponsor: National Cancer Institute (NCI)
• Information provided by: National Institutes of Health Clinical Center (CC)

Tracking Information

• First Submitted Date: November 3, 1999
• First Posted Date: November 4, 1999
• Last Update Posted Date: April 5, 2018
• Study Start Date: February 3, 1995
• Actual Primary Completion Date: October 15, 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
• Official Title: A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer
• Brief Summary: A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
• Detailed Description: A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Primary Purpose: Treatment
• Condition: Ovarian Neoplasm

Intervention

• Drug: Cyclophosphamide
• Drug: Paclitaxel
• Drug: Cisplatin
• Drug: G-CSF

• Study Arms: Not Provided

Publications *

• Kohn EC, Sarosy GA, Davis P, Christian M, Link CE, Ognibene FP, Sindelar WF, Jacob J, Steinberg SM, Premkumar A, Reed E. A phase I/II study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy of poor-prognosis advanced-stage epithelial ovarian cancer. Gynecol Oncol. 1996 Aug;62(2):181-91. doi: 10.1006/gyno.1996.0213.
• Reed E, Kohn EC, Sarosy G, Dabholkar M, Davis P, Jacob J, Maher M. Paclitaxel, cisplatin, and cyclophosphamide in human ovarian cancer: molecular rationale and early clinical results. Semin Oncol. 1995 Jun;22(3 Suppl 6):90-6.
• Link CJ Jr, Sarosy GA, Kohn EC, Christian MC, Davis P, Adamo DO, Reed E. Cutaneous manifestations of Taxol therapy. Invest New Drugs. 1995;13(3):261-3. doi: 10.1007/BF00873811.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 4, 2018): 66
• Original Enrollment (submitted: June 23, 2005): 80
• Actual Study Completion Date: November 7, 2013
• Actual Primary Completion Date: October 15, 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

• 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.

EXCLUSION CRITERIA:

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00001426
• Other Study ID Numbers: 950055; 95-C-0055
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elise C Kohn, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: November 7, 2013