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

Phase 2

Terminated

• Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer; Mixed Tumor, Mesodermal
• Interventions: Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00322881
• Lead Sponsor: Dana-Farber Cancer Institute

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-08
• Primary Completion: 2008-04
• Study Completion: 2010-04
• Results First Submitted: 2015-01-06
• Results First Submitted QC: 2015-06-12
• Results First Posted: 2015-06-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin/Paclitaxel	Carboplatin	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.
Carboplatin/Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Therapy Completion Rate	6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.	The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States