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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322881
Recruitment Status : Terminated (Early closure based on audit by study investigators after 3 patients died on study.)
First Posted : May 8, 2006
Results First Posted : June 17, 2015
Last Update Posted : September 10, 2018
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, 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.

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:



•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.


  • 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.


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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2010

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 Name: Taxol

Drug: Carboplatin

Primary Outcome Measures :
  1. Therapy Completion Rate [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322881

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02155
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
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Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
Publications of Results:
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Responsible Party: Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute Identifier: NCT00322881    
Other Study ID Numbers: 05-402
First Posted: May 8, 2006    Key Record Dates
Results First Posted: June 17, 2015
Last Update Posted: September 10, 2018
Last Verified: August 2018
Keywords provided by Ursula A. Matulonis, MD, Dana-Farber Cancer Institute:
elderly women
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Mixed Tumor, Mesodermal
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action