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.
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
  Purpose

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.


Condition Intervention Phase
Ovarian Stromal Cancer
Drug: paclitaxel
Drug: carboplatin
Biological: bleomycin sulfate
Drug: etoposide phosphate
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Date of randomization, and death due to any cause, assessed up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 128
Study Start Date: February 2010
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042522

  Show 64 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jubilee Brown Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01042522     History of Changes
Other Study ID Numbers: GOG-0264, NCI-2011-02000, GOG-0264, CDR0000662814, GOG-0264, GOG-0264, U10CA027469
Study First Received: January 1, 2010
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sex Cord-Gonadal Stromal Tumors
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Neoplasms
Bleomycin
Etoposide phosphate
Cisplatin
Etoposide
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014