A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities.

Given these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease.

2. Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings.

3. Age > 18 years.

4. ECOG performance status of < 2.

5. 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 > 1.5 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)

2. Patient has severe or uncontrolled concurrent 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. Patient 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 the time of study entry.