search
Back to results

Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

Primary Purpose

Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
cisplatin
topotecan hydrochloride
filgrastim
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brenner Tumor

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed epithelial ovarian carcinoma No borderline ovarian carcinoma Stage III/IV disease that has been suboptimally or optimally debulked The following histologies are eligible: Adenocarcinoma (unspecified) Mucinous cystadenocarcinoma Clear cell adenocarcinoma Serous cystadenocarcinoma Endometrioid adenocarcinoma Transitional cell carcinoma Malignant Brenner's tumor Undifferentiated carcinoma Mixed epithelial carcinoma Extraovarian papillary serous cystadenocarcinoma Measurable or evaluable disease Performance status - GOG 0-1 Enabling completion of at least 2 courses of therapy Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No myocardial infarction within 6 months No congestive heart failure No unstable or uncontrolled angina No history of cardiac arrhythmia requiring anti-arrhythmia medication No uncontrolled hypertension No hypersensitivity to E. coli-derived drug preparation No active infection No sensory neuropathy No other malignancies within the past 5 years except nonmelanomatous skin cancer No prior chemotherapy No prior radiotherapy Recovered from any recent surgery

Sites / Locations

  • Gynecologic Oncology Group of Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, cisplatin, topotecan hydrochloride)

Arm Description

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Outcomes

Primary Outcome Measures

Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria

Secondary Outcome Measures

Overall survival
Progression-free survival

Full Information

First Posted
November 1, 1999
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00002913
Brief Title
Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
Official Title
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer. II. Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF. III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients. OUTLINE: This is a dose escalation study of topotecan. Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed as clinically indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, cisplatin, topotecan hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CACP, CDDP, CPDD, DDP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Other Intervention Name(s)
hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
G-CSF, Neupogen
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 10 years
Title
Progression-free survival
Time Frame
Up to 10 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed epithelial ovarian carcinoma No borderline ovarian carcinoma Stage III/IV disease that has been suboptimally or optimally debulked The following histologies are eligible: Adenocarcinoma (unspecified) Mucinous cystadenocarcinoma Clear cell adenocarcinoma Serous cystadenocarcinoma Endometrioid adenocarcinoma Transitional cell carcinoma Malignant Brenner's tumor Undifferentiated carcinoma Mixed epithelial carcinoma Extraovarian papillary serous cystadenocarcinoma Measurable or evaluable disease Performance status - GOG 0-1 Enabling completion of at least 2 courses of therapy Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No myocardial infarction within 6 months No congestive heart failure No unstable or uncontrolled angina No history of cardiac arrhythmia requiring anti-arrhythmia medication No uncontrolled hypertension No hypersensitivity to E. coli-derived drug preparation No active infection No sensory neuropathy No other malignancies within the past 5 years except nonmelanomatous skin cancer No prior chemotherapy No prior radiotherapy Recovered from any recent surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Armstrong
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

We'll reach out to this number within 24 hrs