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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02667 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GOG 0170H | |||
| CDR0000439489 | |||
| GOG-0170H | Other Identifier | Gynecologic Oncology Group | |
| GOG-0170H | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.
II. Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.
SECONDARY OBJECTIVES:
I. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
II. Determine the duration of progression-free survival and overall survival of patients treated with this drug.
III. Determine the impact of prognostic variables (e.g., platinum sensitivity, performance status, and cellular histology) in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within approximately 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (vorinostat) | Experimental | Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time at risk will be assessed from the date of registration onto the study and include all eligible patients who receive any study treatment. An analysis of any potential treatment effect on PFS may be conducted against the historical controls provided in GOG 126 and GOG 146 using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity. | At 6 months |
| Toxicity as assessed by CTCAE v 3.0 | Up to 5 years after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response (partial and complete response) rate as according to RECIST s | Up to 5 years | |
| Duration of PFS | From study entry until disease progression, death or date of last contact., assessed up to 5 years |
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Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
Recurrent or persistent disease
Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease
Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
No known brain metastases
Performance status - GOG 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Able to take oral medication
No bowel obstruction
No persistent vomiting
No parenteral feeding
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
No neuropathy (sensory and motor) > grade 1
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No active infection requiring antibiotics
No psychiatric illness or social situation that would preclude study compliance
No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat
No other uncontrolled illness
At least 4 weeks since prior immunotherapy for the malignancy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered
No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease
No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen
No prior vorinostat
At least 1 week since prior hormonal therapy for the malignancy
Concurrent hormone replacement therapy allowed
At least 4 weeks since prior radiotherapy for the malignancy and recovered
No prior radiotherapy to > 25% of bone marrow
At least 4 weeks since prior surgery for the malignancy and recovered
At least 4 weeks since other prior therapy for the malignancy
At least 30 days since prior and no concurrent valproic acid
Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding
No prior anticancer therapy that would preclude study participation
No concurrent combination anti-retroviral therapy for HIV-positive patients
No other concurrent investigational agents
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| Name | Affiliation | Role |
|---|---|---|
| Susan Modesitt | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Duration of survival | From entry into the study to death or the date of last contact, assessed up to 5 years |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |