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Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

Primary Purpose

Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring carboplatin, paclitaxel, elderly women

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age 70 or older Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus Life expectancy greater than 6 months Baseline laboratory values as described in protocol Exclusion Criteria: Active infection requiring antibiotics at the time of starting chemotherapy Prior pelvic radiotherapy > 25% of bone marrow Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs Past history of bone marrow transplantation or stem cell support Known history of central nervous system (CNS) metastasis History of prior malignancy that required prior systemic therapy Clinically significant cardiac disease Uncontrolled diabetes mellitus Any signs of intestinal obstruction Participation in an investigational drug study within three weeks prior to study entry History of psychiatric disability or other central nervous system disorder

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin/Paclitaxel

Arm Description

Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.

Outcomes

Primary Outcome Measures

Therapy Completion Rate
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2006
Last Updated
August 10, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00322881
Brief Title
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Official Title
A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Early closure based on audit by study investigators after 3 patients died on study.
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.
Detailed Description
OBJECTIVES: Primary •To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities. Secondary Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients Assess significant toxicities in this group of patients and compare to a non-elderly population. To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy. Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy. Assess progression-free survival and overall survival for this group. To determine the feasibility of accrual. STATISTICAL DESIGN: Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Mixed Tumor, Mesodermal
Keywords
carboplatin, paclitaxel, elderly women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin/Paclitaxel
Arm Type
Experimental
Arm Description
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Therapy Completion Rate
Description
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
Time Frame
6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 70 or older Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus Life expectancy greater than 6 months Baseline laboratory values as described in protocol Exclusion Criteria: Active infection requiring antibiotics at the time of starting chemotherapy Prior pelvic radiotherapy > 25% of bone marrow Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs Past history of bone marrow transplantation or stem cell support Known history of central nervous system (CNS) metastasis History of prior malignancy that required prior systemic therapy Clinically significant cardiac disease Uncontrolled diabetes mellitus Any signs of intestinal obstruction Participation in an investigational drug study within three weeks prior to study entry History of psychiatric disability or other central nervous system disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Matulonis, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19058838
Citation
Matulonis UA, Krag KJ, Krasner CN, Atkinson T, Horowitz NS, Lee H, Penson RT. Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Mullerian tumors. Gynecol Oncol. 2009 Feb;112(2):394-9. doi: 10.1016/j.ygyno.2008.10.015. Epub 2008 Dec 5.
Results Reference
result

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Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

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