Expired Study
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Philadelphia, Pennsylvania 19103


Purpose:

Phase II trial to study the effectiveness of irofulven in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.


Study summary:

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


Criteria:

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 platinum - 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


Study is Available At:


Original ID:

NCI-2012-02512


NCT ID:

NCT00053365


Secondary ID:

NCI-2012-02512


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

61


Enrollment Type:

Actual


Overall Contact Information

Official Name:Russell Schilder
Principal Investigator
Gynecologic Oncology Group

Study Dates

Start Date:June 2003
Completion Date:July 2010
Completion Type:Actual
Primary Completion Date:July 2010
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 22, 2019
First Received Date:January 27, 2003
First Results Date:August 12, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Tumor Response
Time Frame:From entry into study until documented progression or death, assessed up to 5 years.
Safety Issues:False
Description:Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) o
Outcome Type:Primary Outcome
Measure:Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame:Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Progression-free Survival
Time Frame:From entry into study to death or date of last contact, assessed up to 5 years
Safety Issues:False
Description:Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appea

Study Interventions

Intervention Type:Drug
Name:irofulven
Description:Given IV
Arm Name:Treatment (irofulven)
Other Name:6-hydroxymethylacylfulvene

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (irofulven)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)
Agency Class:Other
Agency Type:Collaborator
Agency Name:Gynecologic Oncology Group

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Schilder RJ, Blessing JA, Shahin MS, Miller DS, Tewari KS, Muller CY, Warshal DP, McMeekin S, Rotmensch J. A phase 2 evaluation of irofulven as second-line treatment of recurrent or persistent intermediately platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group trial. Int J Gynecol Cancer. 2010 Oct;20(7):1137-41.
PMID:21495215

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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