search
Back to results

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

Primary Purpose

Ovarian Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Paclitaxel
Cisplatin
G-CSF
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasm focused on measuring Ovarian Cancer, Initial Therapy, Paclitaxel, Cisplatin, Cyclophosphamide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
April 4, 2018
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001426
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 7, 2013
Overall Recruitment Status
Completed
Study Start Date
February 3, 1995 (undefined)
Primary Completion Date
October 15, 2007 (Actual)
Study Completion Date
November 7, 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasm
Keywords
Ovarian Cancer, Initial Therapy, Paclitaxel, Cisplatin, Cyclophosphamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
G-CSF

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise C Kohn, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8751547
Citation
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.
Results Reference
background
PubMed Identifier
7541159
Citation
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.
Results Reference
background
PubMed Identifier
8729957
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs