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Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
ifosfamide
hyperthermia treatment
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University Hospital - Campus Virchow KlinikumRecruiting
  • Krankenhaus NordwestRecruiting
  • University Medical Center Hamburg - EppendorfRecruiting
  • Universitaets - Kinderklinik - LuebeckRecruiting
  • Kreiskrankenhaus TrostbergRecruiting
  • Peterfy Korhaz Szulo-Nobeteg OztalyRecruiting
  • Academisch Medisch Centrum at University of AmsterdamRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
August 6, 2013
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00045461
Brief Title
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Official Title
A Randomized Phase II/III Trial Comparing Carboplatin-Ifosfamide (IC)-Chemotherapy Vs. IC-Chemotherapy Combined With Extreme Whole Body Hyperthermia In Patients With Recurrence Of Epithelial Ovarian Carcinoma: DOLPHIN-1-STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
October 2002
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Compare the time to progressive disease in patients with recurrent ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer treated with carboplatin and ifosfamide with or without whole body hyperthermia. Compare the response rate, duration of response, and survival time of patients treated with these regimens. Compare the effect on the presence of disseminated tumor cells in bone marrow in patients treated with these regimens. Compare the toxicity of these regimens in these patients. Assess quality of life of patients treated with these regimens. OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study. Phase II: Patients receive ifosfamide IV over 1 hour and carboplatin IV over 20 minutes on day 1. Patients also undergo whole body hyperthermia for at least 1 hour on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Phase III (after successful treatment of 15 patients in phase II): Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive ifosfamide, carboplatin, and whole body hyperthermia as in phase II. Arm II: Patients receive ifosfamide and carboplatin as in arm I. In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years. Patients are followed at 4 weeks and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment
Primary Outcome Measure Information:
Title
Time to progressive disease
Title
Response rate
Title
Duration of response
Title
Survival time
Title
Effects on the presence of disseminated tumor cells in bone marrow
Title
Toxicity
Title
Quality of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Sommer, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Charite University Hospital - Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Hildebrandt, MD
Phone
49-30-450-553-636
Email
bert.hildebrandt@chu-ite.de
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
D-60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elke Jaeger, MD
Phone
49-69-7601-3380
Facility Name
University Medical Center Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Hegewisch-Becker, MD
Phone
49-40-428-033-971
Email
hegewisch@uke.uni-hamburg.de
Facility Name
Universitaets - Kinderklinik - Luebeck
City
Luebeck
ZIP/Postal Code
D-23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Bakhshandeh-Bath, MD
Phone
0049-451-500-2316
Email
bakhshan@medinf.mu_luebeck.de
Facility Name
Kreiskrankenhaus Trostberg
City
Trostberg
ZIP/Postal Code
D-83308
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Biedermann, MD
Phone
0862-11-87-5020
Facility Name
Peterfy Korhaz Szulo-Nobeteg Oztaly
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Kornya, MD
Phone
36-1-322-3450
Facility Name
Academisch Medisch Centrum at University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneke M. Westermann, MD, PhD
Phone
31-20-566-5955
Email
a.m.westermann@amc.uva.nl

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

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