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A Phase I Study of Oral Fluoropyrimidine Capecitabine (Xeloda Roche) Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Study of Oral Fluoropyrimidine Capecitabine (Xeloda Roche) Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System


OBJECTIVES:

- Determine the dose-limiting toxicity, maximum tolerated dose, and the recommended phase
II dose of capecitabine and cisplatin in patients with locally advanced or metastatic
cancer of the upper gastrointestinal tract (GI), head and neck, lung, breast, or
carcinoma of unknown primary.

- Determine the toxic effects of this regimen in these patients.

- Evaluate possible antitumor effectiveness of this regimen in these patients.

- Determine the toxic effects of cisplatin and capecitabine at the recommended phase II
dose in patients with cancer of the upper GI tract.

- Determine the overall survival, time to progression, and duration of response in
patients treated with this regimen.

OUTLINE: This is a dose-escalation study of capecitabine.

Patients receive oral capecitabine twice daily for 5, 10, or 14 days. Patients also receive
cisplatin IV on day 1 of each course. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity (DLT). The recommended phase II dose is defined as the
dose preceding the MTD, provided no more than 3 of 12 patients experience DLT at that dose.
Twenty additional patients with cancer of the upper gastrointestinal tract receive treatment
with cisplatin and capecitabine at the recommended phase II dose for at least 6 months in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 6 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 20-50 patients will be accrued for this study within 1-3
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic or locally advanced inoperable carcinoma of the
upper gastrointestinal tract, head and neck, lung, breast, or carcinoma of unknown
primary

- Previously treated and/or resected primary tumors allowed

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Not specified

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin less than 2 mg/dL*

- AST less than 3 times upper limit of normal (ULN)*

- Alkaline phosphatase no greater than 3 times ULN* NOTE: * Unless related to tumor
(e.g., cholangiocarcinoma or hepatic metastases)

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

- BUN no greater than 30 mg/dL* NOTE: * Unless related to tumor (e.g.,
cholangiocarcinoma or hepatic metastases)

Other:

- No other medical condition that could interfere with oral medication absorption

- No prior or concurrent malignancy except surgically cured carcinoma of the cervix or
basal cell or squamous cell carcinoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 months since prior fluorouracil or cisplatin

- At least 3 weeks since other prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068434

NCT ID:

NCT00010023

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • recurrent non-small cell lung cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • metastatic gastrointestinal carcinoid tumor
  • recurrent gastrointestinal carcinoid tumor
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • small intestine adenocarcinoma
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • recurrent small intestine cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • pulmonary carcinoid tumor
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III basal cell carcinoma of the lip
  • stage III verrucous carcinoma of the oral cavity
  • stage III mucoepidermoid carcinoma of the oral cavity
  • stage III adenoid cystic carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV basal cell carcinoma of the lip
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV adenoid cystic carcinoma of the oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent basal cell carcinoma of the lip
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • 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 III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • newly diagnosed carcinoma of unknown primary
  • carcinoma of the appendix
  • recurrent carcinoma of unknown primary
  • gastrointestinal stromal tumor
  • recurrent salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • stage IV pancreatic cancer
  • Digestive System Neoplasms

Name

Location

NYU Cancer Institute at New York University Medical CenterNew York, New York  10016