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Clinical Trials/CTRI/2007/091/000013
CTRI/2007/091/000013CompletedPhase 2

A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel, cisplatin and 5-FU in Patients with LocallyAdvanced Head and Neck (H&N) Cancer . - A Phase IIb RCT of Neoadjuvant chemotherapy comparing Paclitaxel, ifosfamide and Cisplatin with Paclitaxel, cisplatin and 5-FU in Patients with LocallyAdvanced Head and Neck (H&N) Cancer .

Indian Cooperative Oncology Network ICO0 sites100 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • •Signed written informed consent
  • •1) Patients must be willing and able to give written informed consent.
  • •Target population
  • •2) Patients with histologically proven undifferentiated carcinoma or squamous cell
  • •carcinoma (except thyroid cancer) of the oral cavity, nasopharynx, oropharynx,
  • •hypopharynx, nasal cavity, paranasal sinus, or larynx
  • •3) Patients with locally advanced, Stage III-IV (except M1), head and neck cancer.
  • •4) Patients with at least one measurable lesion according to the RECIST criteria
  • •(Section 7.3.2.1).
  • •5) Patients who have not been previously treated for head and neck cancer (surgery,
  • •radiation, and chemotherapy, etc)
  • •6) Patients with ECOG Performance status of 0 - 1 (Appendix 3)
  • •7) Patients with normal hematologic, hepatic, and renal function as defined by the
  • •following criteria:
  • •−Neutrophil count: ≥1,500/L
  • •−Platelet count: ≥100,000/L
  • •−Hemoglobin amount: ≥9.0 g/dL
  • •−Serum AST and serum ALT: ≤2.5 x upper normal limit of the each site serum
  • •total bilirubin: ≤1.25 x upper normal limit of each site
  • •−Serum creatinine: ≤upper normal limit of each site (in case of values above the
  • •upper normal limit, refer to the Calculated Creatinine Clearance 60 ml/min (see
  • •Appendix 6)
  • •8) Patients with a life expectancy of at least 3 months.
  • •9) Men and Women, with ages ranging from 18 to 75 years.
  • •Women of child bearing potential (WOCBP) must have a negative serum or urine
  • •pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
  • •72 hours prior to the start of study medication. WOCBP include any female who has
  • •experienced menarche and who has not undergone successful surgical sterilization
  • •(hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not
  • •postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone
  • •replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH)
  • •level 35 mIU/mL]. Even women who are using oral, implanted or, injectable
  • •contraceptive hormones or mechanical products such as an intrauterine device or barrier
  • •methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing
  • •abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of
  • •child bearing potential.

Exclusion Criteria

  • •Sex and Reproductive Status Exceptions
  • •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 4 weeks after the study.
  • •2) Women who are pregnant or breastfeeding
  • •3) Women with a positive pregnancy test on enrollment or prior to study drug
  • •administration.
  • •4) Sexually active males unwilling to practice contraception during the study
  • •Medical History and Concurrent Diseases
  • •5) Patients with a history of another malignancy (except cured basal cell carcinoma of
  • •skin or cured carcinoma in-situ of uterine cervix)
  • •6) Patients with organ allografts (kidney, liver, heart, and lung, etc)
  • •7) Patients with clinically significant cardiac disease (e.g. congestive heart failure,
  • •symptomatic coronary artery disease and cardiac arrhythmias) not well controlled
  • •with medication) or a myocardial infarction within the last 6 months
  • •8) Patients with evidence of central nervous system metastases.
  • •9) Patients with a history of uncontrolled seizures, central nervous system disorders or
  • •psychiatric disabilities that may preclude adequate informed consent or compromise
  • •compliance with treatment, as judged by the investigator.
  • •10) Patients with serious uncontrolled inter-current infections or HIV infection.
  • •11) Patients with active gastrointestinal bleeding.
  • •12) Patients who have undergone major surgery within 4 weeks of the start of study
  • •13) Patients with pre-existing neuropathy ≥ CTC grade 2 (Appendix 4)
  • •Allergies and Adverse Drug Reactions
  • •14) Patients with a history of hypersensitivity related to the administration of
  • •polyoxyethylene-castor-oil (Cremophor EL)(e.g., cyclosporin), or hardened castor
  • •oil (e.g., vitamin preparations for injection, etc).
  • •15) Patients who received other investigational drug(s) within 6 months prior to study
  • •16) Patients that the investigator judges as inappropriate to participate in this study.

Investigators

Sponsor
Indian Cooperative Oncology Network ICO

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