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

NCT00053365 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02512CDR0000269484GOG-0146OU10CA027469
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

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

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

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

Secondary Outcomes (1)

• Progression-free Survival

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

Study Arms (1)

Treatment (irofulven)

EXPERIMENTAL

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

Interventions

irofulven DRUG

Given IV

Also known as: 6-hydroxymethylacylfulvene, HMAF, MGI 114, MGI-114

Treatment (irofulven)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

irofulven

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Melissa Leventhal
• Organization: Gynecologic Oncology Group

mleventhal@gogstats.org

716-845-4030

Study Officials

• Russell Schilder

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: June 1, 2003
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 24, 2019
• Results First Posted: December 19, 2013

Record last verified: 2019-07

Locations

US (1)