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Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

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.
 
ClinicalTrials.gov Identifier: NCT00611962
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE January 28, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date February 11, 2008
Study Start Date  ICMJE December 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients [ Time Frame: during the study conduct ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals [ Time Frame: During the study conduct ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
Official Title  ICMJE Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors
Brief Summary To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin [hCG], alpha fetoprotein [AFP]) criteria in metastatic germ cell cancer patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms, Germ Cell and Embryonal
Intervention  ICMJE Drug: Oxaliplatin, Paclitaxel

Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient

Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL.

Other Name: Eloxatin®, Taxol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2008)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP level and/or hCG level (> or =to 100 x ULN) when a biopsy was not available
  • Metastatic GCT patients:
  • Progression disease defined as > 10% increase in hCG and/or AFP markers (and/or documented progressive disease [PD]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma)
  • At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted)
  • Eastern Cooperative Oncology Group PS (ECOG PS) grade < or =to 2
  • At least 1 bidimensionally measurable lesion by imaging (CT scan) of > or =to 20 mm outside an irradiated area OR significantly increased tumor markers > 2 x ULN (on > or =to 2 consecutive tests, even in the absence of measurable lesions)
  • Age > or =to 18
  • Adequate bone marrow reserve
  • Neutrophil count > or =to 1500/mm3
  • Platelets > or =to 100,000/mm3
  • Renal function:Creatinine < 3 x ULN
  • Liver function:Transaminases < or =to 2.5 x ULN, total bilirubin < 1.5 x ULN (if liver metastases, transaminases < or =to 5 x ULN)
  • Laboratory values obtained in the week preceding study entry
  • Neurosensory < or =to grade 1 NCI CTC
  • Signed informed consent obtained prior to all study procedures

Exclusion Criteria:

  • Concomitant high-dose steroids (except for antiemetic prophylaxis)
  • Pregnancy, breast-feeding or absence of contraception in sexually active patients
  • Prior treatment with oxaliplatin or taxanes
  • History of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma
  • Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed)
  • Treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study
  • Other serious illness or uncontrolled infection
  • Psychological, social or geographical situation preventing regular follow-up
  • Primary tumor in brain/central nervous system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00611962
Other Study ID Numbers  ICMJE EFC_7407
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nathalie Billon/Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nathalie Billon Sanofi
PRS Account Sanofi
Verification Date January 2008

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