Clinical trial · Interventional

Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

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

NCT00010023CI-TRIAL-00004642completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors .

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
capecitabine	Drug	Capecitabine	ALIAS
cisplatin	Drug	Cisplatin	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTChen TT, Ryan T, Potmesil M, et al.: Cisplatin/capecitabine: tolerance and activity in patients with upper gastrointestinal cancers. [Abstract] American Society of Clinical Oncology 2004 Gastrointestinal Cancers Symposium, 22-24 January 2004, San Francisco, CA. A-53, 2004.

Registry

Dates and enrollment

Start: Aug 1, 2000
Primary completion: Aug 1, 2007
Completion: —
First posted: Jan 27, 2003
Last update posted: Apr 5, 2011
Lead sponsor: NYU Langone Health OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Brief summary (as posted)

Conditions (1)

Interventions (2)

Eligibility (as posted)

Publications (1)

Locations by country (1)