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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00322881
• Other study ID #: 05-402
• Status: Terminated
• Phase: Phase 2
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: August 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Mixed Tumor, Mesodermal
• Ovarian Cancer
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Paclitaxel

• Carboplatin

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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 Müllerian tumors. Gynecol Oncol. 2009 Feb;112(2):394-9. doi: 10.1016/j.ygyno.2008 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.