Clinical trial NCT00322881: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Mixed Tumor, Mesodermal
Keywords: carboplatin
paclitaxel
elderly women
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2006-05-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Therapy Completion Rate
timeFrame: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ursula Matulonis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.