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

NCT ID: NCT00322881

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-04-30

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.

Conditions

Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Mixed Tumor, Mesodermal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin/Paclitaxel

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Interventions

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Other Intervention Names

Taxol

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ursula A. Matulonis, MD

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula Matulonis, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19058838 (View on PubMed)

Other Identifiers

05-402

Identifier Type: -

Identifier Source: org_study_id