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3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
This study has been completed.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081276
  Purpose

RATIONALE: 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.

PURPOSE: 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
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: triapine
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cisplatin 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency and duration of objective response [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
  • Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology) [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2005
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
  • Determine the toxicity of this regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival in patients treated with this regimen.
  • 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
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2 (for patients who received 1 prior treatment regimen)
  • GOG 0-1 (for patients who received 2 prior treatment regimens)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No serious cardiac disease
  • No prior myocardial infarction
  • No uncontrolled congestive heart failure

Pulmonary

  • No pulmonary disease requiring oxygen

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • 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

Endocrine therapy

  • At least 1 week since prior hormonal therapy for malignant tumor
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • No prior cancer therapy that contraindicates receiving study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081276

  Show 31 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Lydia Usha, MD Rush University Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000360854, GOG-0126O
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00081276  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Recurrence
Carcinoma
Genital Diseases, Female
Digestive System Diseases
Cisplatin
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009