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NCT01042522 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
UNKNOWN
Registry last update
2022-01-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Tumor Response Rate

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outcome · POSTED

Overall Survival (OS)

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outcome · NOT POSTED

Change in Inhibin A and Inhibin B Levels

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Carboplatin
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Paclitaxel
    label
    Arm I (paclitaxel, carboplatin)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Biological: Bleomycin Sulfate
    2. Drug: Cisplatin
    3. Drug: Etoposide Phosphate
    4. Other: Laboratory Biomarker Analysis
    label
    Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
    description
    Given IV
    name
    Bleomycin Sulfate
    other Names
    1. Blanoxan
    2. BleMomycine
    3. Blenoxane
    4. Bleo-cell
    5. Bleo-S
    6. Bleocin
    7. Bleolem
    8. Bleomycin Sulfas
    9. Bleomycin Sulphate
    10. Bleomycini Sulfas
    11. Blexane
    12. Oil Bleo
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I (paclitaxel, carboplatin)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carboplatinum
    6. Carbosin
    7. Carbosol
    8. Carbotec
    9. CBDCA
    10. Displata
    11. Ercar
    12. JM-8
    type
    DRUG
  3. arm Group Labels
    1. Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  4. arm Group Labels
    1. Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
    description
    Given IV
    name
    Etoposide Phosphate
    other Names
    1. Etopophos
    type
    DRUG
  5. arm Group Labels
    1. Arm I (paclitaxel, carboplatin)
    2. Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  6. arm Group Labels
    1. Arm I (paclitaxel, carboplatin)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
63
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models.
    measure
    Change in Inhibin A and Inhibin B Levels
    time Frame
    Baseline to up to 2 years
primary Outcomes
  1. description
    The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
    measure
    Progression-free Survival (PFS)
    time Frame
    From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.
secondary Outcomes
  1. description
    Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR).
    measure
    Tumor Response Rate
    time Frame
    Median followup time was 48 months.
  2. description
    The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.
    measure
    Overall Survival (OS)
    time Frame
    From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.
Full study description
brief 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.
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: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (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. 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.
Source references
references
  1. citation
    Brown J, Miller A, Holman LL, Backes F, Nagel C, Bender D, Miller DS, Powell MA, Westin SN, Bonebrake A, Muller CY, Secord AA, Crane E, Schorge J, Tew WP, Sood AK, Bookman MA, Aghajanian C, Gershenson DM. Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14. Gynecol Oncol. 2024 Nov;190:283-290. doi: 10.1016/j.ygyno.2024.09.002. Epub 2024 Sep 12.
    pmid
    39265466
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice