Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
Condition: Ovarian Granulosa Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sertoli-Leydig Cell Tumor; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Sex Cord-Stromal Tumor; Ovarian Sex Cord-Stromal Tumor, Not Otherwise Specified; Ovarian Steroid Cell Tumor
MeSH terms: Neoplasms; Sex Cord-Gonadal Stromal Tumors; Granulosa Cell Tumor; Leydig Cell Tumor; Sertoli-Leydig Cell Tumor
Intervention: Bleomycin Sulfate; Carboplatin; Cisplatin; Etoposide Phosphate; Laboratory Biomarker Analysis; Paclitaxel
Intervention description: Given IV; Given IV; Given IV; Given IV; Correlative studies; Given IV
Intervention MeSH terms: Paclitaxel; Etoposide; Cisplatin; Carboplatin; Albumin-Bound Paclitaxel; Bleomycin; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies paclitaxel and carboplatin to see how well they work
      compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with
      sex cord-ovarian stromal tumors that have spread to other places in the body and usually
      cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs
      used in chemotherapy work in different ways to stop the growth of tumor cells, either by
      killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving
      more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known
      which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor,
             ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid
             (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord
             tumor with annular tubules]

          -  Patients must have newly diagnosed, stage IIA - IV disease and must be entered within
             eight weeks from surgery; they may have either measurable residual disease by Response
             Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable
             residual disease; OR, they must have biopsy-proven recurrent disease of any stage and
             have never received cytotoxic chemotherapy

          -  Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2

          -  Patients of childbearing potential must have a negative serum pregnancy test and must
             agree to practice an effective means of birth control

          -  Patients in the measureable disease cohort must have at least one "target lesion" to
             be used to assess response on this protocol as defined by RECIST 1.1; 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 at least 90
             days following completion of radiation therapy

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to
             Common Terminology Criteria for Adverse Events (CTCAE) grade 1

          -  Platelet greater than or equal to 100,000/mcl

          -  Creatinine no greater than the institutional upper limits of normal

          -  Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less
             than or equal to 3.0 x ULN (CTCAE grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)

          -  Neuropathy (sensory and motor) less than or equal to CTCAE grade 1

          -  No signs of clinically significant hearing loss

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients must have pulmonary function sufficient to receive bleomycin, with normal
             lung expansion, absence of crackles on auscultation, and normal carbon monoxide
             diffusion (DLCO), defined as greater than 80% predicted

          -  Patients with a history of hypersensitivity reactions to prior chemotherapy
             administered for previous cancer diagnoses are eligible to participate in the study,
             unless the hypersensitivity reaction consisted of anaphylaxis not amenable to
             desensitization

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients must be entered within 8 weeks after surgery performed for either 1)
                  initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of
                  recurrent disease in a chemonaive patient

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

        Exclusion Criteria:

          -  Patients who have received any prior cytotoxic chemotherapy or biologics for sex
             cord-stromal tumors (SCSTs)

          -  Patients with apparent stage I disease who have not undergone a staging procedure

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
             being present within the last five years

          -  Woman who are pregnant or breastfeeding

          -  Patients with medical history or conditions not otherwise previously specified which
             in the opinion of the investigator should exclude participation in this study; the
             investigator can consult the study chair or study co-chairs for uncertainty in this
             regard