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A Phase II Trial of Adjuvant Radiation Therapy With Ifosfamide in Patients With MMT of the Uterus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark H. Einstein, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00231842
First received: October 3, 2005
Last updated: April 22, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Histologically documented mixed mesodermal tumor (MMT) of uterus with no visible residual disease.
  2. Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling.
  3. 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.
  4. Age >= 18 years.
  5. ECOG performance status of <2.
  6. Written voluntary informed consent.

Exclusion Criteria:

  1. 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 >1.5mg/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)
  2. Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  3. Patient has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
  4. Patients with any prior chemotherapy or radiotherapy for pelvic malignancy.
  5. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
  6. Patient has a uterine sarcoma other then mixed mesodermal tumor (MMT).
  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: NCT00231842

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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
Genital Diseases, Female
Uterine Diseases
Mixed Tumor, Mesodermal
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Sarcoma
Urogenital Neoplasms
Ifosfamide
Isophosphamide mustard
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014