NCT00045461

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial, fallopian tube, or peritoneal cancer.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2

Geographic Reach
3 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 7, 2013

Status Verified

October 1, 2002

First QC Date

September 6, 2002

Last Update Submit

August 6, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerrecurrent fallopian tube cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancerstage IV fallopian tube cancerrecurrent primary peritoneal cavity cancerstage IIIA primary peritoneal cavity cancerstage IIIB primary peritoneal cavity cancerstage IIIC primary peritoneal cavity cancerstage IV primary peritoneal cavity cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (7)

  • Time to progressive disease

  • Response rate

  • Duration of response

  • Survival time

  • Effects on the presence of disseminated tumor cells in bone marrow

  • Toxicity

  • Quality of life

Interventions

carboplatinDRUG
ifosfamideDRUG
hyperthermia treatmentPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer * Recurrent disease (any FIGO stage) * Not amenable to curative surgery or radiotherapy alone * Failed prior primary platinum-based therapy at least 6 months after therapy discontinuation * Measurable lesion by CT scan, MRI, chest x-ray, or sonography * Physical examination allowed for documenting lymph node and skin metastases * Physical gynecological examination allowed for well-defined palpable tumor lesions * Increase in CA 125 without any measurable tumor is not acceptable as indication of recurrence * No CNS metastases * No tumor of borderline malignancy PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * ECOG 0-2 Life expectancy * At least 24 weeks Hematopoietic * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic * Not specified Renal * Creatinine clearance at least 60 mL/min * No chronic or acute renal failure Cardiovascular * Cardiovascular function sufficient for hyperthermia treatment by stress-ECG * No cardiomyopathy with impaired ventricular function * No New York Heart Association class III or IV heart disease * No cardiac arrhythmias influencing LVEF and requiring medication * No myocardial infarction or angina pectoris within the past 6 months * No uncontrolled arterial hypertension Pulmonary * Pulmonary function sufficient for hyperthermia treatment by pulmonary function tests Other * No untreated endocrinological disease (e.g., hyperthyroidism or diabetes mellitus) * No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No contraindication against hyperthermia treatment (e.g., photodermatosis, history of malignant hyperthermia, or claustrophobia) * No hypersensitivity to carboplatin, ifosfamide, or any other study medication * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No concurrent cytotoxic or other antineoplastic therapy Endocrine therapy * Concurrent hormone replacement therapy allowed * Concurrent steroid antiemetics allowed Radiotherapy * See Disease Characteristics * At least 1 year since prior radiotherapy (tumoricidal dose) of the pelvis * Concurrent palliative local radiotherapy for painful (nonprogressive) existing lesion is allowed if other measurable sites are present * No concurrent radiotherapy to a second existing lesion Surgery * See Disease Characteristics Other * No prior form of hyperthermic therapy * At least 3 weeks since other medications as part of another clinical study * At least 3 weeks since prior investigational agents * At least 6 weeks since prior betablockers * No concurrent photosensitizing drugs * No concurrent betablockers * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

RECRUITING

Krankenhaus Nordwest

Frankfurt, D-60488, Germany

RECRUITING

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

RECRUITING

Universitaets - Kinderklinik - Luebeck

Lübeck, D-23538, Germany

RECRUITING

Kreiskrankenhaus Trostberg

Trostberg an der Alz, D-83308, Germany

RECRUITING

Peterfy Korhaz Szulo-Nobeteg Oztaly

Budapest, 1076, Hungary

RECRUITING

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinIfosfamideDiathermy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHyperthermia, InducedTherapeutics

Study Officials

  • Harald Sommer, MD

    Ludwig-Maximilians - University of Munich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

June 1, 2000

Last Updated

August 7, 2013

Record last verified: 2002-10

Locations

HU(1)NL(1)DE(5)