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Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002903
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Drug: docetaxel
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

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

Estimated Enrollment: 25
Study Start Date: July 1995
Detailed Description:

OBJECTIVES: I. Determine whether partial or complete responses can be achieved with docetaxel (TXT) in patients with recurrent or refractory disseminated germ cell cancer previously treated with standard-dose chemotherapy. II. Assess the probability of actual response warranting further evaluation of the therapeutic effectiveness of TXT in the case that partial or complete tumor responses are achieved in this patient population. III. Characterize further the toxic effects of TXT in these patients.

OUTLINE: Patients receive intravenous docetaxel over 1 hour every 3 weeks until disease progression, unacceptable toxicity, or at least 3 courses beyond documentation of complete response. Patients may receive concurrent radiotherapy provided not all indicator lesions are included in irradiated field. Resection of residual mature teratoma is allowed no sooner than 8 weeks after therapy provided tumor markers are normalized for at least 4 weeks.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed extragonadal and gonadal germ cell tumor Seminoma and nonseminoma eligible Recurrent or refractory disease despite adequate first-line cisplatin- or carboplatin-based chemotherapy and not amenable to surgery and/or curative radiotherapy Relapse after disease-free interval of 1 or more years ineligible Measurable or evaluable disease with documented progression within 2 months prior to entry Elevated beta human chorionic gonadotropin and alpha-fetoprotein considered evaluable if no other evaluable lesion and provided marker(s): Increased since end of last treatment At least 10 times upper limit of normal unless due to tumor lysis Rising on 3 successive occasions at least 2-3 days apart If no tumor markers available, cytology or histology should be obtained No inadequately treated CNS metastases No pleural or pericardial effusion and/or ascites

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal AST/ALT no greater than 3 times normal Alkaline phosphatase no greater than 2.5 times normal Renal: Creatinine no greater than 1.6 mg/dL Creatinine clearance at least 60 mL/min if creatinine borderline (1.1-1.6 mg/dL) Other: No active infection No severe malnutrition No pre-existing grade 2 or worse neurotoxicity No pre-existing edema No senility or psychosis No other expected difficulties for follow-up including geographic considerations No other malignancy except: Second testicular primary tumor Treated basocellular and planocellular skin carcinoma Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior high dose chemotherapy with or without stem cell transplant At least 3 weeks since chemotherapy and past WBC and platelet nadirs Endocrine therapy: Not specified Radiotherapy: Not amenable to curative radiotherapy At least 3 weeks since radiotherapy and recovered Surgery: Not amenable to surgery

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002903

  Show 49 Study Locations
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Emma Geertruida Elisabeth De Vries, MD, PhD University Medical Centre Groningen
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000065251, EORTC-16945T
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002903  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent malignant testicular germ cell tumor
testicular seminoma
recurrent ovarian germ cell tumor
extragonadal germ cell tumor

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Seminoma
Endocrine System Diseases
Urogenital Neoplasms
Testicular Neoplasms
Ovarian Diseases
Malignant germ cell tumor
Recurrence
Docetaxel
Genital Diseases, Female
Neoplasms, Germ Cell and Embryonal
Testicular cancer
Endocrinopathy
Extragonadal Germ Cell Tumor
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009