NCT01042522|UnknownPhase 2Results

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 Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

GOG Foundation ClinicalTrials.gov

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5 other identifiers

GOG-0264NCI-2011-02000CDR0000662814U10CA180868U10CA027469

Study Type

interventional

Target

Locations

1 country

Sites

219

Timeline

RegisteredJan 2010

StartedFeb 2010

CompletionNov 2022

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Feb 2010

Longer than P75 for phase_2

Geographic Reach

1 country

219 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.7 years study duration

First Submitted

Initial submission to the registry

January 1, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

February 8, 2010

Completed

10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed

Last Updated

January 25, 2022

Status Verified

December 1, 2021

Enrollment Period

10.3 years

First QC Date

January 1, 2010

Results QC Date

July 27, 2021

Last Update Submit

December 30, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
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).
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

Secondary Outcomes (2)

Tumor Response Rate
Median followup time was 48 months.
Overall Survival (OS)
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.

Other Outcomes (1)

Change in Inhibin A and Inhibin B Levels
Baseline to up to 2 years

Study Arms (2)

Arm I (paclitaxel, carboplatin)

EXPERIMENTAL

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: CarboplatinOther: Laboratory Biomarker AnalysisDrug: Paclitaxel

Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

EXPERIMENTAL

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 SulfateDrug: CisplatinDrug: Etoposide PhosphateOther: Laboratory Biomarker Analysis

Interventions

Bleomycin SulfateBIOLOGICAL

Given IV

Also known as: Blanoxan, BleMomycine, Blenoxane, Bleo-cell, Bleo-S, Bleocin, Bleolem, Bleomycin Sulfas, Bleomycin Sulphate, Bleomycini Sulfas, Blexane, Oil Bleo

Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm I (paclitaxel, carboplatin)

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Etoposide PhosphateDRUG

Given IV

Also known as: Etopophos

Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (paclitaxel, carboplatin)Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)

PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (paclitaxel, carboplatin)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.