Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
-
Budapest、匈牙利、1076
- 招聘中
- Peterfy Korhaz Szulo-Nobeteg Oztaly
-
接触：
- L. Kornya, MD
- 电话号码：36-1-322-3450
-
-
-
-
-
Berlin、德国、D-13353
- 招聘中
- Charite University Hospital - Campus Virchow Klinikum
-
接触：
- B. Hildebrandt, MD
- 电话号码：49-30-450-553-636
- 邮箱：bert.hildebrandt@chu-ite.de
-
Frankfurt、德国、D-60488
- 招聘中
- Krankenhaus Nordwest
-
接触：
- Elke Jaeger, MD
- 电话号码：49-69-7601-3380
-
Hamburg、德国、D-20246
- 招聘中
- University Medical Center Hamburg - Eppendorf
-
接触：
- S. Hegewisch-Becker, MD
- 电话号码：49-40-428-033-971
- 邮箱：hegewisch@uke.uni-hamburg.de
-
Luebeck、德国、D-23538
- 招聘中
- Universitaets - Kinderklinik - Luebeck
-
接触：
- A Bakhshandeh-Bath, MD
- 电话号码：0049-451-500-2316
- 邮箱：bakhshan@medinf.mu_luebeck.de
-
Trostberg、德国、D-83308
- 招聘中
- Kreiskrankenhaus Trostberg
-
接触：
- A. Biedermann, MD
- 电话号码：0862-11-87-5020
-
-
-
-
-
Amsterdam、荷兰、1105 AZ
- 招聘中
- Academisch Medisch Centrum at University of Amsterdam
-
接触：
- Anneke M. Westermann, MD, PhD
- 电话号码：31-20-566-5955
- 邮箱：a.m.westermann@amc.uva.nl
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
毒性
|
|
反应速度
|
|
生活质量
|
|
反应持续时间
|
|
生存时间
|
|
疾病进展时间
|
|
Effects on the presence of disseminated tumor cells in bone marrow
|
合作者和调查者
调查人员
- 学习椅：Harald Sommer, MD、Ludwig-Maximilians - University of Munich
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- LMU-DOLPHIN-1
- CDR0000256532 (注册表标识符：PDQ (Physician Data Query))
- EU-20220
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
卡铂的临床试验
-
Zhijie WangPeking University Cancer Hospital & Institute; Hebei Medical University Fourth Hospital尚未招聘
-
Jiangsu Aosaikang Pharmaceutical Co., Ltd.尚未招聘
-
Betta Pharmaceuticals Co., Ltd.招聘中
-
Avistone Biotechnology Co., Ltd.尚未招聘