Full Text View
Tabular View
No Study Results Posted
Related Studies
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002903   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
July 1995
 
 
 
Complete list of historical versions of study NCT00002903 on ClinicalTrials.gov Archive Site
 
 
 
Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
PHASE II TRIAL WITH DOCETAXEL IN PATIENTS WITH RELAPSING GERM CELL CANCER

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.

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.

Phase II
Interventional
Treatment
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Drug: docetaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Netherlands,   Norway,   Portugal,   Spain,   Switzerland,   United Kingdom
 
NCT00002903
 
CDR0000065251, EORTC-16945T
European Organization for Research and Treatment of Cancer
 
Study Chair: Emma Geertruida Elisabeth De Vries, MD, PhD University Medical Centre Groningen
National Cancer Institute (NCI)
April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP