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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Therapy Completion Rate
Condition
Ovarian Cancer
Intervention
Paclitaxel
Study Arms / Comparison Groups
Carboplatin/Paclitaxel
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
April 2006
Completion Date
April 2010
Primary Completion Date
April 2008
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
Gender
Female
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ursula Matulonis, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00322881
Organization ID
05-402
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
Study Sponsor
Ursula Matulonis, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
August 2018