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Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01042522
First received: January 1, 2010
Last updated: March 7, 2014
Last verified: March 2014

January 1, 2010
March 7, 2014
February 2010
January 2024   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Date of randomization, and death due to any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01042522 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.
  • Tumor response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors [ Designated as safety issue: No ]
  • Changes in biomarkers in response to treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced State and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

This randomized phase II trial is studying paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with advanced or recurrent sex cord-ovarian stromal tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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.

PRIMARY OBJECTIVES:

I. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors.

SECONDARY OBJECTIVES:

I. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.

II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.

III. To evaluate response rate in the subset of patients with measurable disease.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tumor tissue for future translational research studies.

II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to presence of measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Stromal Cancer
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Biological: bleomycin sulfate
    Given IV
    Other Names:
    • Blenoxane
    • BLEO
    • BLM
  • Drug: etoposide phosphate
    Given IV
    Other Names:
    • ETOP
    • Etopophos
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Experimental: Arm I
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: paclitaxel
    • Drug: carboplatin
    • Biological: bleomycin sulfate
  • Experimental: Arm II
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: etoposide phosphate
    • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
Not Provided
January 2024   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed ovarian stromal tumor, including the following cell types:

    • Granulosa cell tumor
    • Granulosa 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
  • Meets 1 of the following criteria:

    • Newly diagnosed, stage IIA-IVB disease

      • Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks
      • May or may not have measurable residual disease
    • Biopsy-proven recurrent disease of any stage

      • Chemotherapy-naive disease
  • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess response

    • 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 following completion of radiotherapy
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Pulmonary function sufficient to receive bleomycin sulfate, as indicated by the following:

    • Normal lung expansion
    • Absence of crackles on auscultation
    • Normal DLCO, defined as > 80% predicted
  • History of hypersensitivity reactions to chemotherapy administered for a prior cancer diagnosis allowed, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • No peripheral neuropathy > grade 1
  • No signs of clinically significant hearing loss
  • No other invasive malignancies within the past 5 years except for curatively treated nonmelanoma skin cancer
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation
  • No other concurrent antineoplastic therapy, including cytotoxic therapy, biologic therapy, hormonal therapy, or radiotherapy

    • Concurrent hormone replacement therapy allowed
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • No prior cytotoxic chemotherapy or biologic therapy for sex cord-stromal tumors
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
Female
18 Years and older
No
United States
 
NCT01042522
GOG-0264, NCI-2011-02000, GOG-0264, CDR0000662814, GOG-0264, GOG-0264, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jubilee Brown Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP