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Status:

COMPLETED

Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Ovarian Cancer

Peritoneal Cavity Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride, in terms of response, in patients with platinum-resistant or refractory ovarian epithelial or primar...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
  • Must have one of the following:
  • Measurable disease
  • Evaluable disease AND a CA-125 value that has increased ≥ 2 times the nadir value established after debulking surgery and first-line chemotherapy, confirmed by a second measurement within the past 21 days
  • If a second measurement has not been done, it can be done ≥ 7 days but \< 21 days prior to study treatment
  • Platinum-refractory and/or -resistant disease after first-line chemotherapy
  • Patients retreated with platinum agents (i.e., second relapse) are not eligible
  • Patients treated with first-line triplet therapy (e.g., on clinical trial GOG-182) are eligible
  • Must have had debulking surgery
  • Tissue blocks from this surgery must be available
  • No CNS metastases
  • PATIENT CHARACTERISTICS:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (5 times ULN if there is liver involvement)
  • Creatinine ≤ 1.5 times ULN
  • Hemoglobin ≥ 9.0 g/dL
  • No uncontrolled infection
  • No New York Heart Association class III or IV heart failure
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiogram
  • No seizure disorder
  • No other prior or concurrent malignancy in the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior topotecan hydrochloride
  • More than 4 weeks since prior surgery or procedure involving the peritoneum or pleura
  • CA125 measurements used as basis for enrollment must be made outside of this 4-week window
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to \> 25 % of bone marrow
  • No prior therapy with an anti-epidermal growth factor receptor or anti-HER2 tyrosine kinase inhibitors
  • No prior agents targeting topoisomerase I
  • No prior or concurrent human anti-mouse antibodies (HAMA) in patients with non-measurable disease
  • At least 14 days since prior and no concurrent herbal or dietary supplements
  • Vitamin supplements are allowed unless they include herbal additives
  • At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
  • Rifampin
  • Rifabutin
  • Rifapentine
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Efavirenz
  • Nevirapine
  • Cortisone (\> 50 mg)
  • Hydrocortisone (\> 40 mg)
  • Prednisone (\> 10 mg)
  • Methylprednisolone (\> 8 mg)
  • Dexamethasone (\> 1.5 mg)
  • Oral doses of ≤ 1.6 mg of dexamethasone allowed
  • Modafinil
  • Hypericum perforatum (St. John's wort)
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Itraconazole
  • Ketoconazole
  • Fluconazole (\> 150 mg daily)
  • Voriconazole
  • Delaviridine
  • Nelfinavir
  • Amprenavir
  • Ritonavir
  • Indinavir
  • Saquinavir
  • Lopinavir
  • Verapamil
  • Diltiazem
  • Nefazodone
  • Fluvoxamine
  • Cimetidine
  • Aprepitant
  • Grapefruit or grapefruit juice
  • At least 6 months since prior and no concurrent amiodarone
  • No concurrent participation in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, gene therapy) for symptom control or therapeutic intent

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2012

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00436644

    Start Date

    March 1 2007

    End Date

    November 1 2012

    Last Update

    April 16 2014

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Mayo Clinic Arizona

    Scottsdale, Arizona, United States, 85254

    2

    Mayo Clinic in Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905