Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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Purpose
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 .
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: capecitabine Drug: cisplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Oral Fluoropyrimidine Capecitabine (Xeloda Roche) Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System |
| Study Start Date: | August 2000 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Franco M. Muggia, MD | New York University School of Medicine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00010023 History of Changes |
| Other Study ID Numbers: | CDR0000068434, P30CA016087, NYU-9955, ROCHE-NYU-9955, NCI-G00-1908 |
| Study First Received: | February 2, 2001 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
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 |
Additional relevant MeSH terms:
|
Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Capecitabine Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013