Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Eisai Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00374660
First received: September 8, 2006
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.


Condition Intervention Phase
Liver Cancer
Drug: Irofulven + oxaliplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Confirmed response rate: Hepatocellular Cancer (HCC) Cohort: Response Evaluation Criteria in Solid Tumors (RECIST) criteria. [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]
  • Hormone Refractory Prostate Cancer (HRPC) Cohort: Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and RECIST criteria. [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: HRPC Cohort: confirmed response rate according to RECIST; progression-free survival (PFS) for progression according to RECIST; new bone lesions or skeletal events; PFS according to PSA progression; overall survival. [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]
  • Efficacy: HCC cohort - PFS (RECIST); overall survival [ Time Frame: Every 8 weeks until progression. ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: June 2003
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Irofulven + oxaliplatin

Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. Starting dose 40 mg/m^2, dose escalation 50, 60, 70, and 80 mg/m^2 every 28 days if no dose-limiting toxicity.

Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered in a 30-minute infusion on Days 1 and 15 of a 28-day cycle. Starting dose 0.30 mg/kg, dose escalation to 0.40 mg/kg every 28 days if no dose-limiting toxicity.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.
  2. Malignant solid tumor confirmed by a biopsy sample.
  3. Pancreatic, endometrial, gastric, and hepatocellular cancer patients that have exhausted standard treatment options.
  4. Measurable disease according to RECIST.
  5. 18 years of age or older.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-1.
  7. Life expectancy greater than 3 months.
  8. Previous anticancer treatment must be discontinued at least 4 weeks prior to first dose of study treatment (6 weeks for mitomycin C, 8 weeks for bicalutamide).
  9. Patients of reproductive age must be using effective contraceptive methods.
  10. Negative pregnancy test for patients of reproductive potential.

Exclusion Criteria:

  1. Prior therapy with irofulven or oxaliplatin.
  2. Patients who have had radiation therapy to more than 30% of the bone marrow prior to entry into the study.
  3. Prior chemotherapy with nitrosoureas or high dose carboplatin (AUC > 6), prior mitomycin C cumulative dose greater than or equal to 25 mg/m², prior bone marrow transplant or intensive chemotherapy with stem cell support.
  4. Presence of any serious concomitant systemic disorders incompatible with the study (e.g., uncontrolled congestive heart failure, active infection).
  5. Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry, unless the active malignancy can be unmistakably identified by evidence such as recent biopsies or tumor specific markers.
  6. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.
  7. Pregnant or lactating patients or any patient with childbearing potential not using adequate contraception.
  8. Patients with retinopathy or significant visual impairment not correctable by refractory lens will be enrolled on a case by case basis according to the expected benefit ratio, taking into account the malignant disease and the existence of an objective decreased visual acuity and its degree.

Please note: There are additional criteria that must be met in order to be eligible for this study.

  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: NCT00374660

Locations
France
Bordeaux, France
Clichy, France
Lyon, France
Nice, France
Paris, France
Poitiers, France
Saint Cloud, France
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00374660     History of Changes
Other Study ID Numbers: IROF-017
Study First Received: September 8, 2006
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Irofulven
Oxaliplatin

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Oxaliplatin
Irofulven
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014