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Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical research trials and Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer. Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer  Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
For Condition: Fallopian Tube Cancer,ovarian epithelial cancer,peritoneal cavity cancer
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib with carboplatin and paclitaxel in treating patients who have stage III or stage IV ovarian, fallopian tube, or primaryperitoneal cancer.
Details: OBJECTIVES: - Determine the rate of pathologic complete response (pCR) in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with paclitaxel, carboplatin, and erlotinib. - Determine the degree and type of toxicity of this regimen in these patients. - Correlate pCR with epidermal growth factor receptor (EGFR), p110 truncated EGFR isoform (pEGFR), and related signal transduction pathway protein expression levels in patients treated with this regimen. - Determine changes in EGFR and pEGFR levels and other related signal transduction pathway expression in patients treated with this regimen. - Determine the tolerability of twelve months of maintenance therapy with erlotinib in patients achieving pCR, and measure the progression-free interval of these patients. OUTLINE: This is a non-randomized study. Patients are stratified according to disease stage (stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV). Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve pathologic complete response receive maintenance erlotinib for an additional 12 months. PROJECTED ACCRUAL: A total of 47-77 patients (28-41 for stratum I and 19-36 for stratum II) will be accrued for this study within 9-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary peritoneal, fallopian tube, or ovarian epithelial carcinoma, meeting 1 of the following staging criteria: - Stage III with optimal disease after initial surgery (no more than 1 cm residual disease) - Stage III with suboptimal disease after initial surgery - Stage IV - Must have undergone appropriate initial surgery within the past 12 weeks OR determined to be unresectable at diagnosis - The following subtypes are eligible: - Serous adenocarcinoma - Endometrioid adenocarcinoma - Mucinous adenocarcinoma - Undifferentiated carcinoma - Clear cell adenocarcinoma - Mixed epithelial carcinoma - Transitional cell carcinoma - Malignant Brenner tumor - Adenocarcinoma not otherwise specified - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No HIV-positive patients receiving combination antiretroviral therapy - No history of allergic reaction to compounds of similar chemical or biologic composition to erlotinib or other study agents - No ongoing or active infection - No other uncontrolled concurrent illness - No sensory or motor neuropathy greater than grade 1 - No medical contraindication to study regimen - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No other concurrent investigational agents - No other concurrent anticancer agents or therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephanieBlank, Study Chair, Kaplan Cancer Center
University of Connecticut Cancer Center at University of Connecticut Health Center *Recruiting*
Farmington, Connecticut, 06030
United States
Recruiting Carolyn Runowicz 860-679-2609
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Stephanie Blank 212-263-2668
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Thomas Caputo 212-746-3179
Additional Information:
Study ID Numbers: CDR0000271356; NYU-0230,NYU-1102-590,NCI-5886
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059787
Other Peritoneal Cavity Cancer Studies:
1. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
2. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
4. Adjuvant Intraperitoneal Carboplatin With Paclitaxel in Treating Patients Who Had Initial Debulking Surgery for Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
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Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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