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

Primary Purpose

Neoplasms, Germ Cell and Embryonal

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Oxaliplatin, Paclitaxel
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Germ Cell and Embryonal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients

Secondary Outcome Measures

Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals

Full Information

First Posted
January 28, 2008
Last Updated
January 28, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00611962
Brief Title
Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin
Official Title
Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Germ Cell and Embryonal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Paclitaxel
Other Intervention Name(s)
Eloxatin®, Taxol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals
Time Frame
During the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Billon
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Lyon
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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