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

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:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 May 22, 2013