Radiation Therapy Sandwiched Between Paclitaxel and Carboplatin in Patients With High-risk Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01041027
First received: December 29, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

In this study, radiation is "sandwiched" between paclitaxel/carboplatin chemotherapy in attempts to decrease the chance of the cancer returning in the pelvis or elsewhere in the body. This study will evaluate the tolerability of combining radiation with chemotherapy in this way. We will also evaluate any side effects that patients may experience with this treatment.


Condition Intervention Phase
Endometrial Cancer
Drug: Paclitaxel
Drug: Carboplatin
Radiation: Pelvic and Para-Aortic Radiation 6MV Photon Beam Energy
Radiation: High Dose Radiation
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 Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • To assess and document location of disease recurrence (distant vs. local. vs. both) using this treatment regimen. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To evaluate the toxicity of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the associations of cancer recurrence with tumor tissue expression levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    During weeks 1-9 and weeks 13-21, a diluted solution of Paclitaxel will be infused via a peripheral or central vein over three hours, every 21 days.
    Other Name: Taxol
    Drug: Carboplatin
    During weeks 1-9 and weeks 13-21, a diluted solution of Carboplatin will be infused via a peripheral or central vein, every 21 days.
    Other Name: Paraplatin
    Radiation: Pelvic and Para-Aortic Radiation 6MV Photon Beam Energy
    During weeks 8-12, patient will be given radiation once per day, five days a week, for five weeks.
    Radiation: High Dose Radiation
    During weeks 13-15, patient will be given high dose radiation via a vaginal cylinder, once per week for three weeks.
Detailed Description:
  • Before chemotherapy, patients will receive extra fluid by IV for 2 hours, and will be given medicine to prevent side effects from the chemotherapy drugs.
  • Chemotherapy treatments will be given intravenously in the outpatient clinic. Patients will receive IV paclitaxel/carboplatin chemotherapy every 21 days for 3 cycles.
  • After 3 cycles of chemotherapy, patients will receive external beam radiotherapy. Radiation will be delivered to the patient's pelvis at the dose prescribed by the Radiation Oncologist.
  • External radiation will be given once a day, five days a week (Monday-Friday) for 5 weeks.
  • Patients will then receive internal high-dose radiation, which will be given once a week for three weeks. This type of radiation is given through a vaginal cylinder, a device that is inserted in the vagina that directs the radiation to your tumor. It is a procedure that is done with anesthesia.
  • The 4th cycle of chemotherapy will overlap with the high dose radiation.
  • The remainder of the planned 6 cycles of paclitaxel/carboplatin therapy will continue to be administered every 21 days.
  • Prior to and during the study, tests and procedures will be performed; including physical examinations, routine blood tests, urine tests, ECG, medical history and vital signs, radiologic examinations.
  • The study treatment will proceed as long as the tumor does not grow and the patient isn't experiencing any severe side effects.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:

    1. Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IBG3) with lymphovascular space involvement;
    2. Surgical stage I disease with > 50% myometrial invasion and grade 2 or 3 tumor (ICG2, ICG3);
    3. Any surgical stage II disease (IIA, IIB);
    4. Any surgical stage III disease (IIIA, IIIB, IIIC); and
    5. Any surgical stage IV disease with no residual macroscopic tumor
  • Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard GOG criteria.
  • Age > 18 years.
  • ECOG performance status of < 2.

Exclusion Criteria:

  • Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

    1. Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal
    2. Total serum bilirubin > 1.5 mg/dl
    3. History of chronic or active hepatitis
    4. Serum creatinine > 2.0 mg/dl
    5. Platelets < 100,000/mm3
    6. Absolute neutrophil count (ANC) < 1500/mm3
    7. Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry).
  • Patient has severe or uncontrolled concurrent medical disease (eg Un-controlled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  • Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
  • Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
  • Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years.
  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: NCT01041027

Contacts
Contact: Loraine Centrilla, RN 7180.405.8082 lcentril@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Loraine Centrilla, RN    718-405-8082    lcentril@montefiore.org   
Principal Investigator: Dennis Yi-Shin Kuo, MD         
Sub-Investigator: Mark H. Einstein, MD, MS         
Sub-Investigator: Gary L. Golberg, MD         
Sub-Investigator: Gloria Shining Huang, MD         
Sub-Investigator: Harriet Smith, MD         
Sub-Investigator: David Smotkin, MD         
Sub-Investigator: Nicole Nevadunsky, MD         
Sub-Investigator: Subhakar Mutyala, MD         
Sub-Investigator: Madhur Garg, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Dennis Yi-Shin Kuo, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Dennis Yi-Shin Kuo, MD, Montefiore Medical Center and Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01041027     History of Changes
Other Study ID Numbers: MMC-08-03-060
Study First Received: December 29, 2009
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
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 October 01, 2014