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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00322881
First received: May 5, 2006
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

The main purpose of this trial is to look at how elderly women newly diagnosed with 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 Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Mesodermal Tumors
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the completion rate of six cycles of carboplatin/paclitaxel in this elderly population with no dose reductions because of toxicities. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This trial has now been published with the following reference: Matulonis, U.A., Krag, KJ, Krasner CN, Atkinston T., Horowitz NS, Lee H., Penson RT. Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Mullerian tumors. Gynecologic Oncology 2009:112(2):394-9.


Secondary Outcome Measures:
  • Assess CA125 response rates in this group of patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess significant toxicities in this group of patients and compare to a non-elderly population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assess quality of life changes during chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess overall survival for this group of patients. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2006
Study Completion Date: April 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
    Drug: Carboplatin
    Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
Detailed Description:

There has been little research on women who have ovarian, peritoneal or fallopian tube cancer that are 70 years of age or older. We are interested in finding out the special side effects these patients may have with their chemotherapy treatment. This trial will follow patients while they are receiving standard chemotherapy.

Prior to starting chemotherapy treatment, once during chemotherapy treatment and up to one year following chemotherapy patients will receive 5 questionnaires to complete. These questionnaires will ask questions about quality of life, whether the patient is experiencing neuropathy (tingling and/or pain in the fingertips and toes), the level of tiredness, and what type of activities are performed without difficulty and if their activity level changes while they are receiving chemotherapy.

Blood tests to check the levels of both taxol and carboplatin will be performed just before and during the first cycle of chemotherapy.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 70 or older
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322881

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02155
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
  More Information

No publications provided

Responsible Party: Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00322881     History of Changes
Other Study ID Numbers: 05-402
Study First Received: May 5, 2006
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
carboplatin
paclitaxel
elderly women

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014