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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00611962
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 28, 2008
January 28, 2008
December 2000
Not Provided
Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms, Germ Cell and Embryonal
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00611962
EFC_7407
Not Provided
Nathalie Billon/Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Nathalie Billon Sanofi
Sanofi
January 2008

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