A Phase II Trial of Adjuvant Radiation Therapy With Ifosfamide in Patients With MMT of the Uterus
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Purpose
The optimal sequence and /or modality for adjuvant therapy in the management of MMT clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis.
The concept of sequential chemotherapy/radiation therapy/chemotherapy has been previously reported. The chemotherapeutic agents employed in that trial were cisplatin and epirubicin with a reported survival of 74% in patients with Stage I and II MMT with a median follow-up period of 55 months. Toxicity was reported as tolerable and 98% of patients were able to complete their therapy. Sequential chemotherapy/radiation/chemotherapy has also been investigated in other high risk uterine tumors with a propensity for both distant and local recurrence. A retrospective review of 23 patients treated with radiation "sandwiched" between paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinomas found 5/23 (22%) to have recurred with a median PFI of 16.6 months (range 12.1 - 23 months). The median follow-up was 21 months (range 10-45 months). Of the patients remaining disease-free, the median PFI was 21.4 months (range 10-15 months). Toxicity was acceptable and the regimen was well tolerated. A prospective trial of this regimen is presently ongoing and without unexpected toxicity or morbidity.
The proposed study will sandwich radiation between the two most active chemotherapeutic agents for MMT identified to date (ifosfamide/cisplatin). By doing so, we attempt to decrease both local and distant recurrence, which may translate into an improved progression free interval and possibly even extend survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cancer |
Drug: Ifosfamide Procedure: Radiation Therapy |
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 Adjuvant Radiation Therapy "Sandwiched" Between Ifosfamide in Patients With Mixed Mesodermal Tumors |
- To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of chemotherapy in patients with MMT. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To define patterns of recurrence and one-year recurrence-free survival in patients with MMT treated with "sandwich" therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | February 2003 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Adjuvant Radiation Therapy "Sandwiched" between Ifosfamide in Patients with Mixed Mesodermal Tumors
|
Drug: Ifosfamide
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.
Other Name: Ifosfamide
Procedure: Radiation Therapy
Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IVSS bolus at each ifosfamide dosing followed by 1200mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles. After 3 cycles, RT. After RT, Ifosfamide 1.0gm/m2/day for 5 days. Mesna 333mg/IVSS bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L/day x 5 days. Repeat q21 days x 3 cycles.
Other Name: Pelvic RT, Radiation
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible residual disease.
- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling.
- Surgical staging should be completed £ 6 weeks ± 7 days prior to enrollment. Patients should have recovered from surgery and regained an ECOG performance status of < 2, and have resumption of normal GI function. Patients with incompletely healed incisions are eligible to participate.
- Age >= 18 years.
- ECOG performance status of <2.
- Written voluntary informed consent.
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 >1.5mg/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 medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
- Patients 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 time of study entry.
- Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT).
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: | Mark H Einstein, M.D., M.S. | Montefiore Medical Center and Albert Einstein College of Medicine |
More Information
Publications:
| Responsible Party: | Mark H. Einstein, Director, Clinical Research for Women's Health, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00231842 History of Changes |
| Other Study ID Numbers: | MMC-03-02-040 |
| Study First Received: | October 3, 2005 |
| Last Updated: | April 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Montefiore Medical Center:
|
Mixed Mesodermal Tumor MMT Uterine Cancer Radiation Therapy Chemotherapy |
Additional relevant MeSH terms:
|
Uterine Neoplasms Mixed Tumor, Mesodermal Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Genital Diseases, Female Sarcoma |
Adjuvants, Immunologic Ifosfamide Isophosphamide mustard Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013