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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045461
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: carboplatin Drug: ifosfamide Procedure: hyperthermia treatment Phase 2 Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 241 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2000

Primary Outcome Measures :
  1. Time to progressive disease
  2. Response rate
  3. Duration of response
  4. Survival time
  5. Effects on the presence of disseminated tumor cells in bone marrow
  6. Toxicity
  7. Quality of life

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 65

Performance status

  • ECOG 0-2

Life expectancy

  • At least 24 weeks


  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Not specified


  • Creatinine clearance at least 60 mL/min
  • No chronic or acute renal failure


  • 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 function sufficient for hyperthermia treatment by pulmonary function tests


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No concurrent cytotoxic or other antineoplastic therapy

Endocrine therapy

  • Concurrent hormone replacement therapy allowed
  • Concurrent steroid antiemetics allowed


  • 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


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045461

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Charite University Hospital - Campus Virchow Klinikum Recruiting
Berlin, Germany, D-13353
Contact: B. Hildebrandt, MD    49-30-450-553-636   
Krankenhaus Nordwest Recruiting
Frankfurt, Germany, D-60488
Contact: Elke Jaeger, MD    49-69-7601-3380      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: S. Hegewisch-Becker, MD    49-40-428-033-971   
Universitaets - Kinderklinik - Luebeck Recruiting
Luebeck, Germany, D-23538
Contact: A Bakhshandeh-Bath, MD    0049-451-500-2316   
Kreiskrankenhaus Trostberg Recruiting
Trostberg, Germany, D-83308
Contact: A. Biedermann, MD    0862-11-87-5020      
Peterfy Korhaz Szulo-Nobeteg Oztaly Recruiting
Budapest, Hungary, 1076
Contact: L. Kornya, MD    36-1-322-3450      
Academisch Medisch Centrum at University of Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Anneke M. Westermann, MD, PhD    31-20-566-5955   
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Study Chair: Harald Sommer, MD Ludwig-Maximilians - University of Munich
Layout table for additonal information Identifier: NCT00045461    
Other Study ID Numbers: LMU-DOLPHIN-1
CDR0000256532 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: October 2002
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Body Temperature Changes
Signs and Symptoms
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action