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Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Nasopharyngeal Neoplasms

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Trial Information

Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)


Inclusion Criteria:



- Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC)
with metastatic or recurrent disease that is not amenable to potentially curative
surgery or radiotherapy. They must not have prior chemotherapy for the treatment of
metastatic or recurrent disease.

- Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a
minimum period of 6 weeks has elapsed since the last day of treatment. This includes
the use of carboplatin or cisplatin.

- Patients must have at least one uni-dimensional measurable lesion (according to
RECIST criteria)

- Prior RT or surgery to the target lesion(s) is allowed as long as there is documented
disease progression within the RT/ surgical field, and a minimum period of 6 weeks
has elapsed since the last day of treatment.

- Eastern Cooperative Oncology Group performance status of 0-2

- No serious, uncontrolled medical conditions that may be aggravated by treatment.

- No other malignancy(s), except completely excised basal or squamous cell carcinoma of
the skin, or completely treated carcinoma-in-situ of the cervix.

- Adequate hematological function:absolute granulocyte count > 1.5 x 10^9/L, platelet
count > 100 x 10^9/L

- Adequate renal and hepatic functions:┬Ěserum creatinine < 1.25 x upper normal limit
(UNL) or a calculated creatinine clearance > 50 mL/min┬Ěserum bilirubin < 2 x UNL and
Aspartate aminotransferase/Alanine aminotransferase < 3 x UNL

Exclusion Criteria:

- Prior treatment with Oxaliplatin or Gemcitabine.

- Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or
ototoxicity resulting from prior cisplatin/ carboplatin.

- Active or past history of central nervous system metastasis from the primary tumor

- Potentially life-threatening infections

- Patients have used any investigational drug treatment in the month prior to
inclusion.

- Pregnancy or not exercising appropriate birth control during the course of the study.
Breast-feeding women

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria

Outcome Time Frame:

Baseline to end of study

Safety Issue:

No

Principal Investigator

Iris Chan

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Hong Kong: Department of Health

Study ID:

L_9281

NCT ID:

NCT00436800

Start Date:

March 2005

Completion Date:

October 2008

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Neoplasms
  • Carcinoma
  • Nasopharyngeal Neoplasms

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