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Primary Peritoneal Cavity CancerPhase 2NCT00053365

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

A Phase 2 study testing irofulven in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years, women only
What is being tested?
irofulven
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
Jun 2003to Jul 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 45Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
irofulven
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • irofulvenDrug

    Also called 6-hydroxymethylacylfulvene, HMAF, MGI 114, MGI-114

    Given IV

Study groups in NCT00053365
Study groupRoleWhat they receive
Treatment (irofulven)ExperimentalPatients 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.
Receives: Drug: irofulven

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From entry into study until documented progression or death, assessed up to 5 years.

  2. Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Measured: Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Secondary outcomes (1)

  1. 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.

    Measured: From entry into study to death or date of last contact, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053365
Sponsor's protocol ID
NCI-2012-02512
Other IDs
NCI-2012-02512, CDR0000269484, GOG-0146O, GOG-0146O, U10CA027469
Status last verified
Jul 2019
First submitted
27 Jan 2003
Last updated
24 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irofulven in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Response (time frame: From entry into study until documented progression or death, assessed up to 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00053365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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