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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053365
First received: January 27, 2003
Last updated: April 29, 2014
Last verified: January 2013
  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.


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: irofulven
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor Response [ Time Frame: From entry into study until documented progression or death, assessed up to 5 years. ] [ Designated as safety issue: No ]

    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, Graded According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival and Progression-free Survival [ Time Frame: From entry into study to death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Duration of Progression-free Survival [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: June 2003
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (irofulven)
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.
Drug: irofulven
Given IV
Other Names:
  • 6-hydroxymethylacylfulvene
  • HMAF
  • MGI 114
  • MGI-114

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053365

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Russell Schilder Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053365     History of Changes
Other Study ID Numbers: NCI-2012-02512, NCI-2012-02512, CDR0000269484, GOG-0146O, GOG-0146O, U10CA027469
Study First Received: January 27, 2003
Results First Received: August 12, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Irofulven
Radiation-Sensitizing Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014