Cabazitaxel - PF Induction Chemotherapy

NCT01379339 | Completed Phase 1 DMC

• 3 other identifiers: 11-0646(0001)(01)183133-96-2HS#: 11-00201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the first-cycle maximum tolerated dose (MTD) and recommended Phase II (RP2D) dose of Cabazitaxel when combined with Cisplatin and Follow-Up induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck for three cycles.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Cabazitaxel; Cabazitaxel and Cisplatin; Phase I; PF Induction Chemotherapy; Squamous Cell Carcinoma; Head and Neck; Sanofi-Aventis Oncology; Locally Advanced

Outcome Measures

Primary Outcomes (8)

• Maximum Tolerated Dose (MTD)

  MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.

  at 1 week

• Maximum Tolerated Dose (MTD)

  MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.

  at 4 weeks

• Maximum Tolerated Dose (MTD)

  MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.

  at 7 weeks

• Maximum Tolerated Dose (MTD)

  MTD is defined as the dose level immediately below the DLT. The study will be conducted until MTD and recommended Phase II dose are established.

  at 9 weeks

• Dose-limiting toxicity (DLT)

  DLT is defined as a grade3 toxicity lasting more than 7 days or grade 4 or 5 toxicity, with the exception of febrile neutropenia which will be considered as ½ DLT per full dose per episode. The DLT will be the basis for determining the MTD. Treatment cohorts will be dosed in escalating order only after the safety of the previous dose level is established, or until an MTD has been determined.

  at 1 week

• Dose-limiting toxicity (DLT)

  DLT is defined as a grade3 toxicity lasting more than 7 days or grade 4 or 5 toxicity, with the exception of febrile neutropenia which will be considered as ½ DLT per full dose per episode. The DLT will be the basis for determining the MTD. Treatment cohorts will be dosed in escalating order only after the safety of the previous dose level is established, or until an MTD has been determined.

  at 4 weeks

• Dose-limiting toxicity (DLT)

  DLT is defined as a grade3 toxicity lasting more than 7 days or grade 4 or 5 toxicity, with the exception of febrile neutropenia which will be considered as ½ DLT per full dose per episode. The DLT will be the basis for determining the MTD. Treatment cohorts will be dosed in escalating order only after the safety of the previous dose level is established, or until an MTD has been determined.

  at 7 weeks

• Dose-limiting toxicity (DLT)

  DLT is defined as a grade3 toxicity lasting more than 7 days or grade 4 or 5 toxicity, with the exception of febrile neutropenia which will be considered as ½ DLT per full dose per episode. The DLT will be the basis for determining the MTD. Treatment cohorts will be dosed in escalating order only after the safety of the previous dose level is established, or until an MTD has been determined.

  at 9 weeks

Secondary Outcomes (3)

• Toxicity Profile

  at 9 weeks

• Overall Response Rate

  at 9 weeks

• Progression Free Survival/Overall Survival

  for 3 years

Study Arms (5)

Cabazitaxel 10mg/m2

EXPERIMENTAL

* Cabazitaxel on D1 Dose: 10mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Drug: Cabazitaxel 10mg/m2

Cabazitaxel 12.5mg/m2

EXPERIMENTAL

* Cabazitaxel on D1 Dose: 12.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Drug: Cabazitaxel 12.5mg/m2

Cabazitaxel 15mg/m2

EXPERIMENTAL

* Cabazitaxel on D1 Dose: 15mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Drug: Cabazitaxel 15mg/m2

Cabazitaxel 17.5mg/m2

EXPERIMENTAL

* Cabazitaxel on D1 Dose: 17.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Drug: Cabazitaxel 17.5mg/m2

Cabazitaxel 20mg/m2

EXPERIMENTAL

* Cabazitaxel on D1 Dose: 20mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Drug: Cabazitaxel 20mg/m2

Interventions

Cabazitaxel 10mg/m2 DRUG

* Cabazitaxel on D1 Dose: 10mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Also known as: Cabazitaxel-PF Induction Chemotherapy

Cabazitaxel 10mg/m2

Cabazitaxel 12.5mg/m2 DRUG

* Cabazitaxel on D1 Dose: 12.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Also known as: Cabazitaxel-PF Induction Chemotherapy

Cabazitaxel 12.5mg/m2

Cabazitaxel 15mg/m2 DRUG

* Cabazitaxel on D1 Dose: 15mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Also known as: Cabazitaxel-PF Induction Chemotherapy

Cabazitaxel 15mg/m2

Cabazitaxel 17.5mg/m2 DRUG

* Cabazitaxel on D1 Dose: 17.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Also known as: Cabazitaxel-PF Induction Chemotherapy

Cabazitaxel 17.5mg/m2

Cabazitaxel 20mg/m2 DRUG

* Cabazitaxel on D1 Dose: 20mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days) * Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days) * 5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)

Also known as: Cabazitaxel-PF Induction Chemotherapy

Cabazitaxel 20mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage IV only, previously untreated, locally advanced SCCHN (patients may have had previous surgery, but not chemotherapy or radiotherapy).
• During the dose escalation phase before the MTD and DLT are established for cabazitaxel combined with cisplatin and FU induction chemotherapy primary sites allowed include the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, and unknown primary regardless of Human Papilloma Virus (HPV) status. Metastatic SCCHN will be allowed in escalation phase.
• Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy are established (expansion cohort) primary sites allowed include the oral cavity, oropharynx (HPV negative only), larynx, hypopharynx, nasopharynx, and unknown primary (HPV negative only). No patients with metastases will be allowed in this phase (expansion cohort).
• Age \>/= 18 years
• Eastern Cooperative Oncology Group PS 0-1
• Predicted life expectancy \>/= 12 weeks
• Absolute Neutrophilic Count (ANC) \>/= 1.5 x 10\^9/L, Platelets \>/= 100 x 10\^9/L; bilirubin \</= 1.5 x Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) \</= 2.5 x ULN or \</= 5 x ULN if patient has documented liver metastases; serum creatinine \</= 1.5 x ULN
• Patients in the expansion cohorts must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST)
• Patients must be accessible for repeat dosing and follow-up
• Patients - both males and females - with reproductive potential must agree to practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test at baseline and on Day 1
• Patients must provide verbal and written informed consent to participate in the study

You may not qualify if:

• Locally advanced HPV positive oropharyngeal or unknown primary SCCHN for the expansion cohort only (Once MTD and DLT for cabazitaxel combined with cisplatin and FU induction chemotherapy established).
• History of significant cardiac disease unless the disease is well-controlled
• Grade 2 peripheral neuropathy
• No excessive alcohol consumption will be allowed
• Serious comorbid illness, and involuntary weight loss of more than 20% of body weight in the 3 months preceding study entry
• History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable
• History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
• Pregnant or breast-feeding females Gastrointestinal (GI) abnormalities including inability to take oral medication, requirement for IV alimentation, active peptic ulcer, or prior surgical procedures affecting absorption
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
• Any type of active seizure disorder
• Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
• Use of strong or moderate CYP3A4 or CYP1A2 inhibitors/inducers, with the exception of low-dose steroids, within 14 days prior to Day 1 dosing
• Symptomatic brain metastases that are not stable, require steroids, or that have required radiation within the last 28 days
• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study
• History of Hepatitis C or Human Immunodeficiency Virus (HIV) infection, autoimmune disease, or major organ transplant.

Sponsors & Collaborators

• Krzysztof Misiukiewicz: lead
• Sanofi: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Krzysztof Misiukiewicz, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 23, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

US (1)