Radiation Therapy Sandwiched Between Paclitaxel and Carboplatin in Patients With High-risk Endometrial Cancer
This study is currently recruiting participants.
Verified December 2009 by Montefiore Medical Center
Sponsor:
Montefiore Medical Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Detailed Description:
-
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.
- 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:
- Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IBG3) with lymphovascular space involvement;
- Surgical stage I disease with > 50% myometrial invasion and grade 2 or 3 tumor (ICG2, ICG3);
- Any surgical stage II disease (IIA, IIB);
- Any surgical stage III disease (IIIA, IIIB, IIIC); and
- 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:
- Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal
- Total serum bilirubin > 1.5 mg/dl
- History of chronic or active hepatitis
- Serum creatinine > 2.0 mg/dl
- Platelets < 100,000/mm3
- Absolute neutrophil count (ANC) < 1500/mm3
- 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
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 Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma |
Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial 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 17, 2013