Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
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
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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:
Detailed Description:
-
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)
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
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:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 13, 2013