Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 85	NCI	GOG-0146O NCT00053365

Objectives

1. Determine the antitumor activity of irofulven in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Recurrent or persistent disease



• At least 1 unidimensionally measurable target lesion* defined as:
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

   [Note: *Tumors within a previously irradiated field are not considered target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy]




• Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
  • Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel



• Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)



• Platinum-sensitive disease
  • Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum

     [Note: **Any nonplatinum maintenance or consolidation therapy is not included in the calculation of platinum-free interval]

Prior/Concurrent Therapy:

Biologic therapy

• No prior bone marrow or stem cell transplantation
• At least 3 weeks since prior biologic therapy or immunotherapy for malignant tumor
• One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) allowed

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy and recovered
• No prior irofulven
• No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy

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

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery

• Recovered from recent prior surgery

Other

• At least 3 weeks since any other prior therapy for malignant tumor
• No prior anticancer treatment that would preclude study therapy
• One prior noncytotoxic cytostatic regimen for recurrent or persistent disease allowed

Patient Characteristics:

Age

• 18 to 85

Performance status

• GOG 0-2 for patients who received 1 prior therapy regimen
• GOG 0-1 for patients who received 2 prior therapy regimens

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No prior congestive heart failure requiring medication
• No uncontrolled hypertension within the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
• No history of retinopathy and/or macular degeneration
• No neuropathy (sensory and motor) greater than grade 1
• No active infection requiring antibiotics
• No other illness or condition that would preclude study entry

Expected Enrollment

Approximately 22-60 patients will be accrued for this study within at least 6 months.

Outcomes

Antitumor activity
Toxicity

Outline

Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Russell Schilder, MD, Protocol chair		Ph: 215-728-3545; 888-369-2427 Email: russell.schilder@fccc.edu

Registry Information
Official Title		A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer
Trial Start Date		2003-06-02
Trial Completion Date		2008-07-07 (estimated)
Registered in ClinicalTrials.gov		NCT00053365
Date Submitted to PDQ		2002-12-03
Information Last Verified		2008-04-05
NCI Grant/Contract Number		CA27469

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