SCCA Gynecologic Cancer Clinical Trials

DISEASE CHARACTERISTICS:

• Biopsy confirmed uterine (malignant mixed müllerian tumor) or ovarian carcinosarcoma meeting ≥ 1 of the following criteria:

  • Newly diagnosed disease
  • Stage I-IV* disease
  • Persistent or recurrent disease
  • Chemotherapy-naive disease NOTE: *Unstaged patients (patients who have not had hysterectomy surgery) are eligible and should be included as "unstaged" if the only histologic (pathology) documentation of the disease is a biopsy or curettage of the uterus or ovary; if these patients have documented metastatic disease, it should be assigned the appropriate stage (III/IV)

• Measurable or nonmeasurable disease

  • Measurable disease is defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques (e.g., palpation, plain s-ray, CT scan, MRI) or ≥ 10 mm by spiral CT scan
  • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess disease progression as defined by RECIST criteria
  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

PATIENT CHARACTERISTICS:

• GO performance status 0-2
• Platelet count ≥ 100,000/mm^3
• ANC ≥ 1,500/mm^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Serum albumin ≥ 3 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Neuropathy (sensory and motor) ≤ CTCAE v3.0 grade 1
• No active infection requiring antibiotics
• No concurrent or history of other invasive malignancies, except for nonmelanoma skin cancer, within the past 5 years
• No known hypersensitivity to E. coli-derived drug preparations (pegfilgrastim and filgrastim [G-CSF]), mesna, or other thiol compounds

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from the effects of recent surgery, radiotherapy, or other therapy
• No prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma
• No prior cancer treatment that contraindicates this protocol therapy
• At least 4 weeks since prior adjuvant external beam radiotherapy

• At least 1 week since prior hormonal therapy directed at the malignant tumor

  • Continuation of hormone replacement therapy allowed
• No planned radiotherapy after or during study treatment prior to progression of cancer