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

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irofulven
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (irofulven)

Arm 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.

Outcomes

Primary Outcome Measures

Tumor Response
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) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death.
Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

Secondary Outcome Measures

Progression-free Survival
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 appearance of new lesions within 8 weeks of study entry.

Full Information

First Posted
January 27, 2003
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00053365
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (irofulven)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
irofulven
Other Intervention Name(s)
6-hydroxymethylacylfulvene, HMAF, MGI 114, MGI-114
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Tumor Response
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) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death.
Time Frame
From entry into study until documented progression or death, assessed up to 5 years.
Title
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
Secondary Outcome Measure Information:
Title
Progression-free Survival
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 appearance of new lesions within 8 weeks of study entry.
Time Frame
From entry into study to death or date of last contact, assessed up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Schilder
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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