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

Neoplasms, Germ Cell and Embryonal Clinical Trial

Official title:

Phase II Study of Combined Oxaliplatin and Paclitaxel for Metastatic Germ Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611962
• Other study ID #: EFC_7407
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: January 28, 2008
• Start date: December 2000
• Est. completion date: March 2004

Study information

• Verified date: January 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal

Intervention

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.

Locations

Country	Name	City	State
France	Sanofi-Aventis	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients		during the study conduct	No
Secondary	Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals		During the study conduct	Yes