Study Stopped
Early closure based on audit by study investigators after 3 patients died on study.
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Apr 2006
Typical duration for phase_2 ovarian-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 17, 2015
CompletedSeptember 10, 2018
August 1, 2018
2 years
May 5, 2006
January 6, 2015
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Therapy Completion Rate
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Study Arms (1)
Carboplatin/Paclitaxel
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02155, United States
Related Publications (1)
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.
PMID: 19058838RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study terminated early due to 3 deaths on study and consequently results are limited.
Results Point of Contact
- Title
- Ursula A. Matulonis, MD
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Ursula Matulonis, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 8, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2010
Last Updated
September 10, 2018
Results First Posted
June 17, 2015
Record last verified: 2018-08