A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
Condition: Uterine Cancer
MeSH terms: Carcinoma; Uterine Neoplasms; Cystadenocarcinoma, Serous
Intervention: Carboplatin and Paclitaxel and Pelvic Radiation Therapy; Carboplatin and Paclitaxel and Pelvic Radiation Therapy; Carboplatin and Paclitaxel and Radiation Therapy
Intervention description: Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles; Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles; Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour & Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uterine Papillary Serous Carcinoma; UPSC; Radiation Therapy; Chemotherapy

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.
    

Eligibility 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.