Adjuvant Radiation Therapy With Ifosfamide in Patients With Mixed Mesodermal Tumors of the Uterus

NCT00231842 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 03-02-040
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal sequence and /or modality for adjuvant therapy in the management of Mixed Mesodermal Tumors (MMT) clearly remains to be established. The rationale for the protocol is to "sandwich" pelvic radiation with chemotherapy to decrease distant metastasis. 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.

Conditions

Uterine Cancer

Keywords

Mixed Mesodermal Tumor; MMT; Uterine Cancer; Radiation Therapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Cycles With Hematologic Toxicities

  Out of 162 planned cycles, a total of 138 cycles (85%) were administered. Number of cycles during which participants with grades 3 and 4 experienced hematologic toxicities are reported. Most of the toxicities were self-limiting.

  2 years

Study Arms (1)

Ifosfamide with or without cisplatin

EXPERIMENTAL

Participants with surgically staged carcinosarcoma (CS) with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day for 5 days) with cisplatin (20 mg/m2/day for 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin with cisplatin (20 mg/m2/day for 5 days) evrey 3 weeks. cisplatin added toxicity without additional efficacy, so mid-study, cisplatin was eliminated.

Drug: Ifosfamide; Device: Radiation Therapy; Drug: Cisplatin

Interventions

Ifosfamide DRUG

Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV 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 333 mg/IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.

Ifosfamide with or without cisplatin

Radiation Therapy DEVICE

Ifosfamide 1.2gm/m2/day for 5 days. Mesna 400mg/IV 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 333 mg /IV bolus at each ifosfamide dosing followed by 1000mg IV divided in 3L /day x 5 days. Repeat q21 days x 3 cycles.

Also known as: Pelvic RT, Radiation

Ifosfamide with or without cisplatin

Cisplatin DRUG

dosage is 20 mg/m2/day for 5 days, ever 3 weeks.

Ifosfamide with or without cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \>= 18 years.
• Written voluntary informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Einstein MH, Klobocista M, Hou JY, Lee S, Mutyala S, Mehta K, Reimers LL, Kuo DY, Huang GS, Goldberg GL. Phase II trial of adjuvant pelvic radiation "sandwiched" between ifosfamide or ifosfamide plus cisplatin in women with uterine carcinosarcoma. Gynecol Oncol. 2012 Jan;124(1):26-30. doi: 10.1016/j.ygyno.2011.10.008. Epub 2011 Nov 3.

  PMID: 22055846 RESULT

MeSH Terms

Conditions

Uterine Neoplasms; Mixed Tumor, Mesodermal

Interventions

Ifosfamide; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Mark Einstein, MD, MS
• Organization: Montefiore Medical Center

meinstei@montefiore.org

718-405-8082

Study Officials

• Mark H Einstein, M.D., M.S.

  Montefiore Medical Center and Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research for Women's Health

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: February 1, 2003
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)