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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00322881
• Collaborator: Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 48
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Mixed Tumor, Mesodermal	Drug: Paclitaxel; Drug: Carboplatin	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Paclitaxel; Other Names: Taxol ; Drug: Carboplatin

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02155

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• Brigham and Women's Hospital
• Massachusetts General Hospital

Investigators

• Principal Investigator: Ursula Matulonis, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00322881
• Other Study ID Numbers: 05-402
• First Posted: May 8, 2006
• Last Update Posted: Sep 10, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute: carboplatin; paclitaxel; elderly women
• Additional relevant MeSH terms: Fallopian Tube Neoplasms; Mixed Tumor, Mesodermal; Paclitaxel; Carboplatin

Study Results

Participant Flow

Recruitment Details	12 patients were enrolled between March 26, 2006 and January 2, 2008.

Arm/Group Title	Carboplatin/Paclitaxel
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
COMPLETED	7
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Carboplatin/Paclitaxel
Arm/Group Description	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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	12 100%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	78.3
Sex: Female, Male (Count of Participants)
Female	12 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The analysis dataset is comprised of all treated patients.

Arm/Group Title	Carboplatin/Paclitaxel
Arm/Group Description	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.
Measure Participants	12
Number (90% Confidence Interval) [proportion of participants]	.50 4.2%

Adverse Events

Time Frame	The planned treatment regimen was of fixed duration: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
Adverse Event Reporting Description	Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAE (v3). Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAE (v3).
Arm/Group Title	Carboplatin/Paclitaxel
Arm/Group Description	Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks) Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
All Cause Mortality
	Carboplatin/Paclitaxel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Carboplatin/Paclitaxel
	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)
Blood and lymphatic system disorders
Febrile neutropenia	2/12 (16.7%)
Gastrointestinal disorders
Constipation	1/12 (8.3%)
Nausea	1/12 (8.3%)
Vomiting	1/12 (8.3%)
GI-other	1/12 (8.3%)
General disorders
Fatigue	2/12 (16.7%)
Infections and infestations
Infection w/ gr3-4 neut, anal/perianal	1/12 (8.3%)
Infection-other	1/12 (8.3%)
Investigations
Neutrophils	1/12 (8.3%)
Nervous system disorders
Syncope	1/12 (8.3%)
Renal and urinary disorders
Incontinence urinary	1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	Carboplatin/Paclitaxel
	Affected / at Risk (%)	# Events
Total	9/12 (75%)
Blood and lymphatic system disorders
Hemoglobin	3/12 (25%)
Gastrointestinal disorders
Constipation	6/12 (50%)
Nausea	1/12 (8.3%)
Vomiting	1/12 (8.3%)
General disorders
Fatigue	6/12 (50%)
Injection site reaction	1/12 (8.3%)
Pain NOS	1/12 (8.3%)
Pain-other	1/12 (8.3%)
Infections and infestations
Infection Gr0-2 neut, lung	1/12 (8.3%)
Infection-other	1/12 (8.3%)
Investigations
Leukocytes	2/12 (16.7%)
Neutrophils	2/12 (16.7%)
Platelets	3/12 (25%)
Alkaline phosphatase	1/12 (8.3%)
ALT, SGPT	2/12 (16.7%)
AST, SGOT	1/12 (8.3%)
Creatinine	1/12 (8.3%)
Metabolic/Laboratory-other	1/12 (8.3%)
Metabolism and nutrition disorders
Hypoalbuminemia	2/12 (16.7%)
Hypercalcemia	1/12 (8.3%)
Hypocalcemia	2/12 (16.7%)
Hyperglycemia	2/12 (16.7%)
Hypomagnesemia	4/12 (33.3%)
Hyperkalemia	1/12 (8.3%)
Hypokalemia	1/12 (8.3%)
Hyperuricemia	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Joint, pain	1/12 (8.3%)
Muscle, pain	2/12 (16.7%)
Nervous system disorders
Neuropathy-sensory	6/12 (50%)
Neurologic-other	1/12 (8.3%)
Skin and subcutaneous tissue disorders
Alopecia	7/12 (58.3%)
Rash/desquamation	1/12 (8.3%)

Limitations/Caveats

This study terminated early due to 3 deaths on study and consequently results are limited.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.