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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0126O | |||
| U10CA027469 | U.S. NIH Grant/Contract | View source | |
| CDR0000360854 | Registry Identifier | PDQ (Physician Data Query) |
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Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the duration of progression-free survival and overall survival in patients treated with this regimen.
II. Determine the effects of prognostic variables, including initial performance status, age, and mucinous (or clear cell) histology, in these patients.
OUTLINE: This is a non-randomized study.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 23-48 patients will be accrued for this study within 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (triapine and cisplatin) | Experimental | Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triapine | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and duration of objective response assessed using RECIST criteria | Up to 5 years | |
| Frequency and severity of observed adverse effects assessed using CTCAE version 3.0 | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of progression-free survival | From study entry until disease recurrence, death or date of last contact, assessed up to 5 years | |
| Duration of overall survival | From study entry to death or date of last contact, assessed up to 5 years |
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Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal cancer
At least 1 unidimensionally measurable target lesion
Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
Considered platinum resistant or refractory, according to 1 of the following criteria:
Ineligible for any higher priority GOG protocol
Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN
No serious cardiac disease
No prior myocardial infarction
No uncontrolled congestive heart failure
No pulmonary disease requiring oxygen
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Neuropathy (sensory and motor) ≤ grade 1
No active infections requiring antibiotics
No hearing impairment
No known G6PD deficiency
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
At least 3 weeks since prior biologic or immunologic agents for malignant tumor
One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed
See Disease Characteristics
One prior paclitaxel-containing regimen allowed
No prior 3-AP
No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
Recovered from prior chemotherapy
At least 1 week since prior hormonal therapy for malignant tumor
Concurrent hormone replacement therapy allowed
No prior radiotherapy to more than 25% of marrow-bearing areas
Recovered from prior radiotherapy
Recovered from prior surgery
No prior cancer therapy that contraindicates receiving study therapy
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| Name | Affiliation | Role |
|---|---|---|
| Lydia Usha | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22541066 | Derived | Kunos C, Radivoyevitch T, Abdul-Karim FW, Fanning J, Abulafia O, Bonebrake AJ, Usha L. Ribonucleotide reductase inhibition restores platinum-sensitivity in platinum-resistant ovarian cancer: a Gynecologic Oncology Group Study. J Transl Med. 2012 Apr 27;10:79. doi: 10.1186/1479-5876-10-79. |
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| cisplatin | Drug | Given IV |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology) | Up to 5 years |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C078157 | 3-aminopyridine-2-carboxaldehyde thiosemicarbazone |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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