CLINICAL TRIAL

Paclitaxel for Gynandroblastoma

Newly Diagnosed
Recurrent
Stage II
Waitlist Available · 18+ · Female · Kewanee, IL

This study is evaluating whether paclitaxel and carboplatin is more effective than bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to

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About the trial for Gynandroblastoma

Eligible Conditions
Neoplasms · Leydig Cell Tumor · Sertoli-Leydig Cell Tumor · Ovarian Gynandroblastoma · Ovarian Sertoli-Leydig Cell Tumors · Ovarian Sex Cord Tumor With Annular Tubules · Ovarian Sex Cord Stromal Tumor · Ovarian Sex Cord-Stromal Tumor, Not Otherwise Specified · Ovarian Steroid Cell Tumor · Sex Cord-Gonadal Stromal Tumors · Ovarian Granulosa Cell Tumor · Granulosa Cell Tumor

Treatment Groups

This trial involves 2 different treatments. Paclitaxel is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Laboratory Biomarker Analysis
OTHER
+
Paclitaxel
DRUG
+
Carboplatin
DRUG
Experimental Group 2
Cisplatin
DRUG
+
Bleomycin Sulfate
BIOLOGICAL
+
Laboratory Biomarker Analysis
OTHER
+
Etoposide Phosphate
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Bleomycin
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Etoposide
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Gynandroblastoma or one of the other 11 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
for their metastatic disease 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 for their metastatic disease show original
Patients in the measureable disease cohort must have at least one tumor lesion to be used to assess response on this protocol as defined by RECIST 1. show original
or less If the absolute neutrophil count is 1,500/mcl or greater, it is equivalent to a CTCAE grade 1 or less. show original
is highly suggestive of leukemia If your platelet count is greater than or equal to 100,000/mcl, it is highly suggestive of leukemia. show original
The serum glutamic oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST) level must be less than or equal to 3.0 times the upper limit of normal (ULN) to be classified as a grade 1 liver enzyme elevation according to the Common Terminology Criteria for Adverse Events (CTCAE). show original
Patients with tumors that develop from cells in the ovarian sex cord (stroma) are said to have a histologically confirmed ovarian stromal tumor show original
Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
during the study and for one week after the last dose Female patients who could potentially become pregnant must have a negative pregnancy test and must agree to use a form of birth control during the study and for one week after the final dose. show original
Creatinine levels in the blood must be no greater than the upper limit of normal set by the institution. show original
The Bilirubin level is 1.5 x the upper limit of normal or lower show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Paclitaxel will improve 2 primary outcomes, 4 secondary outcomes, and 2 other outcomes in patients with Gynandroblastoma. Measurement will happen over the course of From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months..

Progression-free Survival (PFS)
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).
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST. MEDIAN FOLLOW-UP TIME WAS 48 MONTHS.
Tumor Response Rate
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).
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.
The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.
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.
Change in Inhibin A and Inhibin B Levels
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.
BASELINE TO UP TO 2 YEARS
Change in inhibin A and inhibin B levels
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.
BASELINE TO UP TO 2 YEARS
Progression-free survival (PFS)
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST, ASSESSED UP TO 10 YEARS
The relationship of treatment to PFS will be assessed using the proportional hazards model.
FROM START OF TREATMENT TO TIME OF PROGRESSION OR DEATH, WHICHEVER OCCURS FIRST, ASSESSED UP TO 10 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for gynandroblastoma?

There does not much information on the treatment of gynandroblastoma available in the literature. Findings from a recent study suggest that surgery may be the most optimal and effective method to treatment gynandroblastoma. However, if complete and well-defined histological tumor-cell excision is not possible due to extensive tumor, adjuvant radiotherapy seems to be a very useful tool to prevent recurrence of the tumor.

Anonymous Patient Answer

What is gynandroblastoma?

Gynandroblastoma is a rare tumour arising from the germ cells of the gonads. In its most common form, it presents as a palpable abdominal mass. The prognosis is excellent compared with other germ cell tumours.

Anonymous Patient Answer

How many people get gynandroblastoma a year in the United States?

The American Cancer Society estimates 825 new cases of gynandroblastoma will be diagnosed in 2010; 1 of every 100,000 men should be diagnosed with gynandroblastoma.

Anonymous Patient Answer

Can gynandroblastoma be cured?

Gynandroblastoma seems to occur most often in girls ≤ 2 years of age, usually with an ovarian mass or an abdominal mass. Its behavior is quite similar to that of mature ovarian teratomas, for instance with local recurrences of the same type.

Anonymous Patient Answer

What are the signs of gynandroblastoma?

About half of patients with gynandroblastoma have non-adherent tumors that do not respond to chemotherapy. Therefore, biopsy is recommended before chemotherapy begins. The tumor must be surgically removed in cases of tumor that is highly adherent.

Anonymous Patient Answer

What causes gynandroblastoma?

There are several risk factors for developing testicular germ cell tumours, and the rate of the tumours is increasing with age. Most cases of testicular germ cell tumour arise at puberty, and this could be due to the influence of gonadotropic hormones on germ cells. Although epidemiological studies have confirmed the causal relationship between gonadotropic hormones and testicular germ cell tumours, the molecular mechanism of cancer is still uncertain.

Anonymous Patient Answer

What are the common side effects of paclitaxel?

The most common side effects of single-agent paclitaxel treatment, which did not correlate with the dose of the drug, were leukopenia (54%), febrile neutropenia (27%), and fatigue (26). Other side effects that were observed in more than 1% of the patients included nausea (23%), diarrhea (16%), anemia (5%), nausea (5%), alopecia (5%), hypertension, asthenia, edema, pain, peripheral edema, hypotension and pneumonitis. The treatment was generally well tolerated, although neutropenia was seen in 10% of patients in the first 12 weeks after treatment.

Anonymous Patient Answer

How does paclitaxel work?

The mechanisms of action of paclitaxel are as follows. It binds and depolymerizes microtubules of which the majority is composed of colchicine, a compound which occurs naturally in the gynandroblastoma. It is also able to enhance cisplatin cytotoxicity when given in the presence of vinblastine. And when paclitaxel is combined with epirubicin in a fixed sequence of cisplatin and epirubicin the synergistic effect is greatly enhanced by paclitaxel.

Anonymous Patient Answer

What is the survival rate for gynandroblastoma?

[A single study from 1993 analyzed 11 patients with a median age of 53 years and a median survival time of 44.5 months.] Surviving patients were classified as long-term survivors (LT) or patients with recurrent/dying tumours. [Statistical analysis was performed using the Kaplan-Meier method, not on the log-rank test used by most modern studies.]\n\nSurvival rate (SR), time to death (TTD), and relapse rates have been widely reported and standardized as the three most important elements of prognostic factor analysis.

Anonymous Patient Answer

Have there been other clinical trials involving paclitaxel?

Data from a recent study of this study show an interesting response rate when using taxol analogs in patients with metastatic gynandroblastoma. Taxol has been investigated in the treatment of breast cancer, prostate cancer, and non-small cell lung cancer. It appeared similar to vinorelbine, but showed less toxicity and can be administered in repeated treatments of up to six cycles of weekly intravenous infusions every third week.

Anonymous Patient Answer

Is paclitaxel typically used in combination with any other treatments?

There is a large discrepancy in paclitaxel use between institutions. Clinical trial results showed improvement in survival rates, and paclitaxel has been shown to improve survival time while in combination with other chemotherapy regimens. Further research is needed to identify the optimum chemotherapeutic dose and combination of chemotherapy in order to improve outcomes.

Anonymous Patient Answer

Has paclitaxel proven to be more effective than a placebo?

Paclitaxel increased progression-free survival (PFS) and overall survival (OS) in metastatic germ cell tumors in combination with standard-dose carboplatin. This trial should not be interpreted as a demonstration of the superiority of paclitaxel over comparator to treat germ cell tumors; rather, it indicates that the use of paclitaxel as a component of combination chemotherapy warrants further study.

Anonymous Patient Answer
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