Table 4.
Ongoing pivotal trials of docetaxel-based chemotherapy (Clinicaltrials.gov 2008)
| Name | Sponsor/collaborator | Primary investigator | Primary site | Planned patient no | Design/disease stage | Treatmentsa | Primary objective | Year started | |
|---|---|---|---|---|---|---|---|---|---|
| Cooperative group or independent investigator-initiated clinical trials | |||||||||
| → Pivotal trials | |||||||||
| 1 | A phase III trial of docetaxel-based chemoradiotherapy plus or minus induction chemotherapy to decrease events in head and neck cancer in N2/N3 stage patients (the DeCIDE trial)
UofC IRB #: 13362B |
University of Chicago | Ezra Cohen, Everett Vokes (co-PIs, University of Chicago, Chicago, IL, USA) | International multicenter | 400 | Randomized, open label, LA SCCHN (only N2/N3) | 2 cycles of TPF ICT vs no induction CT followed by RT plus docetaxel/5-FU and oral hydroxyurea | OS | 2004 |
| 2 | A phase III study of sequential therapy with TPF/chemoradiation vs cisplatin-based chemoradiotherapy with accelerated concomitant boost RTfor LA squamous cell cancer of the head and neck (the PARADIGM trial)
DFCI trial #: 04–006 |
Dana-Farber Cancer Institute (DCFI) | Marshall Posner, Robert Haddad (co-PIs, DCFI, Boston, MA, USA) | International multicenter | 330 | Randomized, open label LA SCCHN | Arm A: 3 cycles of TPF ICT followed by CCRT; splitting of the arm:
Arm A1 (poor response during induction): docetaxel weekly for 4 weeks + RT with accelerated concomitant boost Arm A2 (good response during induction): carboplatin + RT Arm B: no induction CT; cisplatin + RT |
OS | 2004 |
| → Other trials (combining docetaxel with biologics) | |||||||||
| 3 | Larynx preservation with induction chemotherapy (cisplatin, 5-FU, docetaxel) followed by RT combined with either cisplatin or cetuximab in laryngopharyngeal squamous cell carcinoma – a randomized phase II study (the “TREMPLIN” study) | Groupe Oncologie Radiotherapie Tete et Cou (GORTEC)
Groupe d’Etude des Tumeurs de la Tete et du Cou (GETTEC) |
Jean-Louis Lefebvre (PI, Centre Oscar Lambret, Lille, France) | France, multicenter | 156 | Randomized, open label, parallel group LA SCC larynx | 3 cycles of TPF followed by RT plus either 3-wkly cisplatin x 3 or cetuximab (loading dose then wkly) for 8 cycles (only in patients with >50% response to TPF) | Laryngeal preservation rate | 2005 |
| 4 | Phase II trial of combination weekly bortezomib (Velcade®) and docetaxel (Taxotere®) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
(VICC study #: HN0501) |
Vanderbilt-Ingram Cancer Center (VICC) NCI | Christine Chung (Study Chair, VICC, Nashville, TN, USA) | US, multi-center | 50 | Open label Recurrent/metastatic SCCHN | IV docetaxel plus IV bortezomib on Days 1 and 8, every 4 wks | ORR | 2005 |
| 5 | A phase II study of bevacizumab (Avastin®) in combination with docetaxel and radiation on LA squamous cell cancer of the head and neck
(CASE CCC Study #: 6304) |
Case-Western
Reserve – Ireland Comprehensive Cancer Center (CWRU ICC) NCI |
Panos Savvides (Study Chair, Case Comprehensive Cancer Center, Cleveland, OH, USA) | Case Comprehensive Cancer Center, Cleveland, OH, USA) | 30 | Open label LA SCCHN | RT once daily, 5 days per wk for 8 wks plus IV docetaxel once per wk for 8 wks plus IV bevacizumab every 2 wks for up to 1 year | TTP | 2005 |
| 6 | Phase III trial of TPF induction therapy + cisplatin/5-fluorouracil with concomitant RT with or without cetuximab (Erbitux®) in patients with squamous cell carcinoma of the head and neck
(the AVAPO trial) |
SS Giovanni and Paolo Hospital (Associazione Volontari Assistenza Pazienti Oncologia: AVAPO) | Adriano Paccagnella, PI, SS Giovanni and Paolo Hospital, Venice, Italy | Italy, Multicenter | 350 | Randomized, parallel group LA SCCHN | Arm A: induction chemotherapy (TPF every 3 wks for 3 cycles) then cisplatin + 5-fluororacil + RT ± cetuximab
Arm B: cisplatin + 5-fluororacil + RT ± cetuximab (no induction CT) |
OS | 2007 |
| 7 | EORTC 24061: Randomized phase II feasibility study of cetuximab (Erbitux®) combined with 4 cycles of TPF followed by platinum-based chemoradiation strategies | European Organisation for Research and Treatment of Cancer (EORTC) Head and Neck Group | Jan Baptiste Vermorken (Study coordinator, Universitair Ziekenhuis Antwerpen, Edegem, Belgium) | EU, multicentre | 55 | Randomized, parallel group LA SCCHN | Arm A: induction with TPF (2 or 4 cycles depending on progression) followed by CCRT with wkly cisplatin
Arm B: induction with TPF (2 or 4 cycles depending on progression) followed by CCRT with wkly carboplatin Both arms receive weekly cetuximab throughout |
Feasibility of delivery of the regimens based on ≥80% of the per-protocol dose intensity of RT, platinum and cetuximab during the CCRT phase | Projected: Q2 2008 |
| 8 | Organ preservation trial for advanced primary untreated squamous cell carcinoma of the pharynx and larynx (Stage III/IV) | Dept of ORL and Head and Neck Surgery, University Clinic – Frankfurt, Frankfurt, Germany | Rainald Knecht (Chief Investigator, University Clinic – Frankfurt, Frankfurt, Germany) Volker Budach (Chief Co-Investigator, Klinik und Poliklinik fuer Strahlentherapie, University Clinic – Berlin, Berlin, Germany) | Germany, multicenter | 328 | Open label, randomized, phase III LA SCCHN | Group 1: TPF (every 3 wks for 3 cycles) followed by accelerated RT with concomitant boost + cetuximab
Group 2: no induction CT; accelerated RT with concomitant boost + cetuximab |
OS | Projected: Q2 2008 |
| Pharma-sponsored clinical trials (combining docetaxel with biologics) | |||||||||
| 9 | Randomized phase II study of docetaxel in combination with vandetanib (Zactima®, ZD6474) in patients with LA squamous cell carcinoma of the head and neck | DFCI
Brigham and Women’s Hospital (BWH) Beth Israel Deaconess Medical Center (BIDMC) Massachusetts General Hospital (MGH) AstraZeneca |
Robert Haddad (PI, DFCI, Harvard Medical School, Boston, Massachusetts, USA) | US, multicenter | 72 | Phase II, randomized, open label, parallel group LA SCCHN | Docetaxel once every 3 wks plus vandetanib once daily | Response rate | March 2007 |
| 10 | Phase II trial of docetaxel, cetuximab (C225; Erbitux®), and cisplatin followed by radiation, cetuximab, and cisplatin in LA head and neck cancer | University of Pittsburgh Bristol-Myers Squibb (BMS) | Athanassios (Ethan) Argiris (PI, University of Pittsburgh, Pittsburgh, PA, USA) | University of Pittsburgh, Pittsburgh, PA, USA | 40 | Phase II, open label, non-randomized, parallel group LA SCCHN | Docetaxel plus cetuximab plus cisplatin followed by RT + cetuximab + cisplatin | Objective response rate | 2005 |
| 11 | A randomized, open-label, controlled, phase II trial of combination chemotherapy with or without panitumumab (Vectibix®) as first-line treatment of subjects with metastatic or recurrent head and neck cancer, and cross-over second-line panitumumab monotherapy of patients who fail the combination chemotherapy (the PARTNER trial: Panitumumab Added to Regimen for Treatment of head and Neck cancer – Evaluation of Response) | Amgen | Company-coordinated trial | Amgen Research Site, Paducah, KY, USA | 150 | Phase II, randomized, open label, parallel group Recurrent/metastatic SCCHN | Docetaxel plus cisplatin ± panitumumab | PFS | 2007 |
| 12 | Phase I evaluation of erlotinib (Tarceva®) and docetaxel with concomitant boost radiation for locoregionally advanced squamous cell carcinoma of the head and neck | University of Texas – M.D. Anderson Cancer Center Genentech
(Also supported – but not sponsored – by sanofi-aventis) |
Bonnie S. Glisson (PI, M.D. Anderson Cancer Center, Houston, TX, USA) | M.D. Anderson Cancer Center, Houston, TX, USA | 24 | Phase I, non-randomized, open label | Docetaxel 15 or 20 mg/m2 on Days 1, 8, 15, and 22 plus oral erlotinib 100, 125, or 150 mg on all other days the patient is not receiving docetaxel + RT (includes concomitant boost) | Maximum tolerated dose of docetaxel + erlotinib during concomitant boost radiation | 2005 |
| 13 | Phase I sequential therapy: Panitumumab (Vectibix®) (P)-TPF plus P-CT chemoradiotherapy
DFCI Trial #: 05–401 |
DFCI Amgen | Marshall Posner, Robert Haddad (co-PIs, DFCI, Boston, MA, USA) | US, single center | 24 | Phase I, non-randomized, open label | Docetaxel + cisplatin + 5-FU + panitumumab, every 3 wks for 3 cycles, followed by panitumumab + carboplatin + paclitaxel with daily RT | Maximum tolerated dose of docetaxel and panitumumab in the delivered schema | 2007 |
| 14 | GSTTC: one-step four-arm randomized trial of TPF induction chemotherapy followed by PF + cetuximab (Erbitux®) in patients with squamous cell carcinoma of the head and neck | Gruppo di Studio sui Tumori della Testa e Collo (GSTTC) Merck KGaA | Adriano Paccagnella, PI, Venice, Italy | Italy, multi-center | 300 | Randomized, parallel group | Arm A: TPF induction chemotherapy then either PF or cetuximab
Arm B: no induction therapy, followed by either PF or cetuximab |
ORR; TTP | Projected: 2008 |
| 15 | DFCI: TPF plus cetuximab (Erbitux®) (TPF-3) phase I trial of sequential chemotherapy and cetuximab
DFCI Trial #: 06–128 |
DFCI
BMS |
Robert Haddad (PI, DFCI, Harvard Medical School, Boston, MA, USA) | US, multi-center | 30–40 | Phase I, non-randomized, open label | TPF + cetuximab followed by platinum-based chemoradiotherapy | Maximum tolerated dose of docetaxel and cetuximab in the delivered schema | 2007 |
Abbreviations: 5-FU, 5-fluororoucil; IV, intravenous; LA, locally advanced; ORR, overall response rate; PFS, progression-free survival; PI, principal investigator; RT, radiotherapy; SCCHN, squamous cell carcinoma of the head and neck; TPF, docetaxel + cisplatin + 5-fluorouracil; TTP, time to progression.