Cisplatin and Radiation Therapy With or Without Gemcitabine Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced Nasopharyngeal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00997906
First received: October 17, 2009
Last updated: October 20, 2009
Last verified: October 2009

October 17, 2009
October 20, 2009
September 2009
Not Provided
Overall survival at 5 years [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997906 on ClinicalTrials.gov Archive Site
  • Metastases-free survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Tumor recurrence [ Designated as safety issue: No ]
  • Second primary malignancy [ Designated as safety issue: No ]
  • Toxicity according to the Common Toxicity Criteria [ Designated as safety issue: Yes ]
  • Quality of life as measured by the EORTC QLQ-C30 [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cisplatin and Radiation Therapy With or Without Gemcitabine Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced Nasopharyngeal Cancer
A Randomised Phase ll/Lll Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy my kill more tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with nasopharyngeal cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together with radiation therapy works compared with giving cisplatin and radiation therapy together with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally advanced nasopharyngeal cancer.

OBJECTIVES:

Primary

  • To compare the 5-year overall survival of patients with locally advanced nasopharyngeal cancer treated with concurrent cisplatin and radiotherapy with vs without induction chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.

Secondary

  • To assess and compare the disease-free survival, distant metastases rate, toxicities, and quality of life of patients treated with these regimens.

OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
  • Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: carboplatin
    Given IV
  • Drug: cisplatin
    Given IV
  • Drug: gemcitabine hydrochloride
    Given IV
  • Drug: paclitaxel
    Given IV
  • Radiation: intensity-modulated radiation therapy
    Given once daily 5 days a week for 6½ weeks
  • Experimental: Arm I
    Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
    Interventions:
    • Drug: cisplatin
    • Radiation: intensity-modulated radiation therapy
  • Experimental: Arm II
    Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.
    Interventions:
    • Drug: carboplatin
    • Drug: cisplatin
    • Drug: gemcitabine hydrochloride
    • Drug: paclitaxel
    • Radiation: intensity-modulated radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
216
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed nasopharyngeal cancer

    • Loco-regionally advanced disease (International Union Against Cancer [IUCC] stage III or IV [T3-4, any N or any T, N2-3])
    • WHO type II or III disease
    • No evidence of metastatic disease in staging work up (including lung, liver, and bone imaging)
  • Must have undergone cross-sectional imaging of the primary and neck disease (MRI)
  • Evaluable disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,000/mm^3
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 10 g/dL
  • Serum creatinine normal
  • Creatinine clearance > 50 mL/min
  • Serum alkaline phosphatase < 2 times normal
  • SGOT < 2 times normal
  • Total bilirubin < 24 μmol/L
  • No uncontrolled hypercalcemia (calcium ≥ 2.7 mmol/L [10.8 mg/dL])
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraceptives
  • No second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
  • No serious active infection
  • Not a hepatitis B carrier
  • No other serious concurrent systemic disorders deemed incompatible with the study by the investigator

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment including chemotherapy or radiotherapy
Both
18 Years and older
No
Singapore
 
NCT00997906
CDR0000657121, SINGAPORE-NCC0901
Not Provided
Not Provided
National Cancer Centre, Singapore
Not Provided
Principal Investigator: Terence Tan, FRCR National Cancer Centre, Singapore
National Cancer Institute (NCI)
October 2009

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