Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
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| ClinicalTrials.gov Identifier: NCT01042522 |
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Recruitment Status :
Active, not recruiting
First Posted : January 5, 2010
Results First Posted : January 25, 2022
Last Update Posted : January 25, 2022
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Sponsor:
GOG Foundation
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Biological: Bleomycin Sulfate Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Phosphate Other: Laboratory Biomarker Analysis Drug: Paclitaxel | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary |
| Actual Study Start Date : | February 8, 2010 |
| Actual Primary Completion Date : | June 12, 2020 |
| Estimated Study Completion Date : | November 2, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
Drug Information available for:
Bleomycin sulfate
Bleomycin
Cisplatin
Paclitaxel
Etoposide
Carboplatin
Etoposide phosphate
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (paclitaxel, carboplatin)
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.
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Drug: Carboplatin
Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Drug: Paclitaxel Given IV
Other Names:
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Experimental: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
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.
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Biological: Bleomycin Sulfate
Given IV
Other Names:
Drug: Cisplatin Given IV
Other Names:
Drug: Etoposide Phosphate Given IV
Other Name: Etopophos Other: Laboratory Biomarker Analysis Correlative studies |
Primary Outcome Measures :
- 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. ]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).
Secondary Outcome Measures :
- Tumor Response Rate [ Time Frame: Median followup time was 48 months. ]
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).
- 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. ]The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.
Other Outcome Measures:
- Change in Inhibin A and Inhibin B Levels [ Time Frame: Baseline to up to 2 years ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042522
Locations
Show 219 study locations
Sponsors and Collaborators
GOG Foundation
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jubilee Brown | NRG Oncology |
Study Documents (Full-Text)
Documents provided by GOG Foundation:
Documents provided by GOG Foundation:
Study Protocol and Statistical Analysis Plan [PDF] June 13, 2016
| Responsible Party: | GOG Foundation |
| ClinicalTrials.gov Identifier: | NCT01042522 |
| Other Study ID Numbers: |
GOG-0264 NCI-2011-02000 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000662814 GOG-0264 ( Other Identifier: NRG Oncology ) GOG-0264 ( Other Identifier: CTEP ) U10CA180868 ( U.S. NIH Grant/Contract ) U10CA027469 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 5, 2010 Key Record Dates |
| Results First Posted: | January 25, 2022 |
| Last Update Posted: | January 25, 2022 |
| Last Verified: | December 2021 |
Additional relevant MeSH terms:
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Neoplasms Sex Cord-Gonadal Stromal Tumors Granulosa Cell Tumor Leydig Cell Tumor Sertoli-Leydig Cell Tumor Neoplasms, Gonadal Tissue Neoplasms by Histologic Type Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Testicular Neoplasms Genital Neoplasms, Male Testicular Diseases Paclitaxel Etoposide Cisplatin Carboplatin Albumin-Bound Paclitaxel Bleomycin Etoposide phosphate Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |