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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
  Purpose

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


Condition Intervention Phase
Neoplasms, Germ Cell and Embryonal
 Drug: Oxaliplatin, Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: December 2000
Study Completion Date: March 2004
Intervention Details:
    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
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611962

Locations
France
Sanofi-Aventis
Lyon, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Billon Sanofi
  More Information

No publications provided

Responsible Party: Nathalie Billon/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00611962     History of Changes
Other Study ID Numbers: EFC_7407
Study First Received: January 28, 2008
Last Updated: January 28, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Oxaliplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013