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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: carboplatin
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Radiation: intensity-modulated radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 216
Study Start Date: September 2009
Arms Assigned Interventions
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).
Drug: cisplatin
Given IV
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 6½ weeks
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.
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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997906

Locations
Singapore
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Terence Tan, FRCR    65-6-321-4204      
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
Principal Investigator: Terence Tan, FRCR National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00997906     History of Changes
Other Study ID Numbers: CDR0000657121, SINGAPORE-NCC0901
Study First Received: October 17, 2009
Last Updated: October 20, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 22, 2014