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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045461
First received: September 6, 2002
Last updated: August 6, 2013
Last verified: October 2002
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progressive disease [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Effects on the presence of disseminated tumor cells in bone marrow [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 241
Study Start Date: June 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00045461

Locations
Germany
Charite University Hospital - Campus Virchow Klinikum Recruiting
Berlin, Germany, D-13353
Contact: B. Hildebrandt, MD    49-30-450-553-636    bert.hildebrandt@chu-ite.de   
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    hegewisch@uke.uni-hamburg.de   
Universitaets - Kinderklinik - Luebeck Recruiting
Luebeck, Germany, D-23538
Contact: A Bakhshandeh-Bath, MD    0049-451-500-2316    bakhshan@medinf.mu_luebeck.de   
Kreiskrankenhaus Trostberg Recruiting
Trostberg, Germany, D-83308
Contact: A. Biedermann, MD    0862-11-87-5020      
Hungary
Peterfy Korhaz Szulo-Nobeteg Oztaly Recruiting
Budapest, Hungary, 1076
Contact: L. Kornya, MD    36-1-322-3450      
Netherlands
Academisch Medisch Centrum at University of Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Anneke M. Westermann, MD, PhD    31-20-566-5955    a.m.westermann@amc.uva.nl   
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Study Chair: Harald Sommer, MD Ludwig-Maximilians - University of Munich
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00045461     History of Changes
Other Study ID Numbers: LMU-DOLPHIN-1, CDR0000256532, EU-20220
Study First Received: September 6, 2002
Last Updated: August 6, 2013
Health Authority: Unspecified

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:
Fallopian Tube Neoplasms
Fever
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Body Temperature Changes
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Signs and Symptoms
Urogenital Neoplasms
Carboplatin
Ifosfamide
Isophosphamide mustard
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014