3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer |
Drug: triapine Drug: cisplatin Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma |
- Frequency and duration of objective response assessed using RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects assessed using CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Duration of progression-free survival [ Time Frame: From study entry until disease recurrence, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
- Duration of overall survival [ Time Frame: From study entry to death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
- Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (triapine and cisplatin)
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.
|
Drug: triapine
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Recurrent or persistent disease
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Outside a previously irradiated field
Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
- Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment
Considered platinum resistant or refractory, according to 1 of the following criteria:
- Treatment-free interval of less than 6 months after platinum-based therapy
- Disease progression during platinum-based therapy
- 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
Contacts and Locations
More Information
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00081276 History of Changes |
| Other Study ID Numbers: | NCI-2012-02585, GOG-0126O, U10CA027469, CDR0000360854 |
| Study First Received: | April 7, 2004 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Ovarian Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013