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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/24/2017
Start Date:February 8, 2010

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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

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.

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.

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 measurable 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
We found this trial at
196
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Radhika P. Gogoi
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1201 Camino de Salud Northeast
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(505) 272-4946
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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524 South Park Street
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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4805 Northeast Glisan Street
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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1200 Old York Road
Abington, Pennsylvania 19001
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1500 East Medical Center Drive
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400 South Clark Street
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211 Saint Francis Drive
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789 Mt Auburn Rd
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160 S Adams St
Carthage, Illinois 62321
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Chapel Hill, North Carolina 27599
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5841 S Maryland Ave
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5100 W Broad St
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3535 Olentangy River Rd
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3100 Plaza Properties Blvd
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111 S Grant Ave
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810 Jasonway Avenue
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5201 Harry Hines Blvd
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Decatur, Illinois 62526
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2300 N Edward St
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561 W. Central Avenue
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561 West Central Avenue
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Galesburg, Illinois 61401
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1400 29th Street South
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406-454-2171
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1117 29th St S
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
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Green Bay, Wisconsin 54301
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Green Bay, Wisconsin 54303
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Green Bay, Wisconsin 54303
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Hartford, Connecticut 6102
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Hazleton, PA
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Helena, Montana 59601
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Helena, MT
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Hinsdale, Illinois 60521
Principal Investigator: Sudarshan K. Sharma
Phone: 630-654-1790
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Hinsdale, IL
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Houston, Texas 77030
Principal Investigator: Robert L. Coleman
Phone: 713-792-3245
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Houston, TX
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Indianapolis, Indiana 46260
Principal Investigator: Michael J. Callahan
Phone: 317-338-2194
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Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: David P. Bender
Phone: 800-237-1225
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Iowa City, IA
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 776-5660
Green Bay Oncology - Iron Mountain We are one of a select few physician groups...
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Iron Mountain, MI
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
(573) 632-4800
Principal Investigator: James L. Wade
Phone: 309-243-3605
Capital Region Medical Center-Goldschmidt Cancer Center At the Goldschmidt Cancer Center in Jefferson City, board...
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Jefferson City, MO
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Joplin, Missouri 64804
Principal Investigator: Jay W. Carlson
Phone: 800-821-7532
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Joplin, MO
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Principal Investigator: Jay W. Carlson
Phone: 800-821-7532
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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Joplin, MO
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