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A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer

Phase 2
18 Years
85 Years
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase II Evaluation Of Irofulven (IND #55804, NSC #683863) In The Treatment Of Recurrent Or Persistent Platinium-Sensitive Ovarian Or Primary Peritoneal Cancer


I. Determine the antitumor activity of irofulven in patients with persistent or recurrent
platinum-sensitive ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.


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.

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

Inclusion Criteria:

- 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

- 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

- Performance status - GOG 0-2 for patients who received 1 prior therapy regimen

- Performance status - GOG 0-1 for patients who received 2 prior therapy regimens

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- 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

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No prior congestive heart failure requiring medication

- No uncontrolled hypertension within the past 6 months

- 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

- 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

- 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

- At least 1 week since prior hormonal therapy for malignant tumor

- Concurrent hormone replacement therapy allowed

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

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

- Recovered from recent prior surgery

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response, as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Russell Schilder

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103