Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Paclitaxel; Cetuximab + Paclitaxel
Intervention description: Paclitaxel 80 mg/m2 may be infused, intravenously, every week.; Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Cetuximab; Erbitux; Paclitaxel; Extreme; Metastatic; Recurrent

Summary:

      Treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) after
      progression to first line EXTREME-type treatment in patients undergoing maintenance treatment
      with cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed the informed consent

          2. Age ≥ 18 and < 75 y

          3. ECOG (Eastern Cooperative Oncology Group)performance status: 0-1

          4. Life expectancy of at least 12 weeks

          5. Histological or cytological confirmation of head & neck squamous cell carcinoma with
             localization in larynx, oropharynx, oral cavity or hypopharynx.

          6. Having received at least 2 cycles of EXTREME-type chemotherapy (cisplatin or
             carboplatin + fluoropyrimidines + cetuximab) and being in maintenance phase with
             cetuximab because of having reached CR (Complete response), PR (Partial response) or
             SD (Stable disease) to said treatment

          7. At least one measureable lesion by CT scan or MRI

          8. Adequate bone marrow, liver and kidney function, according to:

               -  Hb (Hemoglobin) ≥ 9.0 g/dl

               -  Platelets 100,000/mm3

               -  ANC (Absolute Neutrophil Count) ≥ 1,500/mm3

               -  Total bilirubin ≤ 2 times the UNL

               -  SGPT/ALT and SGOT/AST ≤ 3 x UNL (Upper normal limit)

               -  Alkaline phosphatase ≤ 2.5 x UNL

               -  Serum creatinine ≤ 1.5 times the ULN or creatinine clearance > 50 ml/min

          9. Adequate nutritional status: weight loss < 20% in relationship to usual weight or
             albumin ≥ 35 g/l, in the last 12 w

         10. Seric calcium adjusted to albumine lower or equal to 1,25 UNL.

         11. Toxicity, due to previous treatment received, resolved to grade 1, before enrolment in
             the study

         12. Women of childbearing potential should have a (-)ve pregnancy test in serum or urine,7
             d before randomization. Postmenopausal women should have remained amenorrheic for at
             least 12 m. Furthermore, all men as well as women who participate in this study should
             use effective contraceptive methods beginning with the signing of the informed consent
             form and up to at least 6 m after the completion of the study or of the last dose,
             whichever occurs first

        Exclusion Criteria:

          1. Treatment for recurrent and/or metastatic disease other than the EXTREME- type first
             line (cisplatin or carboplatin + fluoropyrimidines + cetuximab)

          2. Non-measurable lesion as only evidence of disease

          3. Nasopharyngeal carcinoma

          4. Clinical or radiographic evidence of brain metastases

          5. Having history of or presenting clinically significant cardiovascular disease, such
             as, but not limited to, congestive heart failure, ≥ grade II of the NYHA, severe
             cardiac arrhythmias that require medication, or ≥ grade II peripheral vascular
             disease. Furthermore, those patients who have suffered myocardial infarction or
             unstable angina in the year prior to the onset of the study treatment or a recent
             onset angina in the last 3 m will also be excluded

          6. History of or current presence of grade >1 peripheral neuropathy

          7. History of active neurological disease

          8. History of uncontrolled convulsive episode

          9. Current ≥ 2 grade infection

         10. Known infection by HIV or chronic infection by HBV or HBC or presence of uncontrolled
             and severe intercurrent infections or other severe and uncontrolled concomitant
             diseases

         11. History of uncontrolled diabetes, uncontrolled HBP or hepatic condition.

         12. History of pulmonary fibrosis, acute pulmonary damage or interstitial pneumonia

         13. Any antineoplastic treatment within the 4 w prior to the randomization period

         14. History of another neoplastic disease during the last 5 y, with the exception of cured
             "in situ" basal cell ca.skin carcinoma, "in situ" ca.bladder, "in situ" ca.cervix and
             "in situ" ca.prostate

         15. Known allergy or suspicion of allergy or hypersensitivity to any component of
             cetuximab or paclitaxel

         16. Previous treatment with monoclonal antibodies or other signal transduction inhibitors
             or EGFR-targeted treatment (Except for previous treatment with cetuximab)

         17. Known drug abuse (exception Alcoholism)

         18. Any important and uncontrolled medical, psychological, psychiatric, geographic or
             social problem that may interfere in the participation of the subject in the study and
             that does not allow for adequate follow-up and compliance with the protocol and
             evaluation of the study results

         19. Women who are pregnant or in breast-feeding period

         20. Use of any investigational new drug within the 4 w prior to randomization