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Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields


OBJECTIVES:

- Determine the therapeutic activity of lurtotecan liposome in patients with metastatic
or loco-regionally recurrent squamous cell carcinoma of the head and neck.

- Determine the objective response, duration of response, and time to progression in
patients treated with this drug.

- Determine the toxicity profile of this drug in these patients.

- Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in
these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to presence of a
target lesion in a previously irradiated field (within vs outside).

Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck

- Metastatic or loco-regionally recurrent disease

- No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas

- No tumors of the nasal or paranasal cavities or of the nasopharynx

- Measurable disease

- No clinical symptomatic evidence of brain or leptomeningeal metastases

- Ineligible for loco-regional treatment after chemotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal:

- Creatinine no greater than 1.5 times ULN

- No uncontrolled hypercalcemia

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- No known hypersensitivity to systemic liposomal formulations or compounds chemically
related to study drug

- No uncontrolled systemic disease or infection

- No psychological, familial, sociological, or geographical condition that would
preclude study

- No other prior or concurrent malignancy except adequately treated cone-biopsied
carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent anticancer biological therapy or immune response modifiers

- No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for recurrent disease

- No prior therapy with camptothecin analogues

- At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy

- No other concurrent anticancer cytotoxic therapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- At least 30 days since prior experimental drug

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Florence Duffaud, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CHU de la Timone

Authority:

United States: Federal Government

Study ID:

EORTC-16008

NCT ID:

NCT00022594

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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