Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Study of Weekly Topotecan and Gefitinib (Iressa) in Patients With Platinum-Resistant Ovarian, Peritoneal, of Fallopian Tube Cancer
Verified date | January 2022 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purposes of this study are: 1. To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) weekly of topotecan in combination with standard dose gefitinib in patients with relapsed, platinum-resistant, ovarian, peritoneal or fallopian tube cancers that are epidermal growth factor receptor (EGF-R) positive (>/= 1+). 2. To determine the response rate and response duration in this patient population treated with the maximum tolerated dose (MTD) of topotecan administered on a weekly schedule in combination with standard dose gefitinib, given by way of the mouth (PO) daily.
Status | Completed |
Enrollment | 19 |
Est. completion date | November 4, 2020 |
Est. primary completion date | November 4, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Women with platinum-resistant, histologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer. Resistance is defined as: Progression of disease during platinum chemotherapy, or progression of disease within 6 months of completing platinum chemotherapy, or failure to achieve a complete response, with persistent macroscopic disease, after an adequate trial of primary therapy. - EGF-R expression must be positive (e.g., 1+ or greater) See appendix G. - Patients with a known hypersensitivity to platinum compounds, who have failed a desensitization regimen, or in the opinion of the investigator, are not good candidates for desensitization, are eligible. - Patients must have measurable disease. - Unlimited number of prior chemotherapy regimens are allowed. - Zubrod performance status </= 2. - Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine </= 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < /=2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) </= 2X ULN; white blood count (WBC) >/= 3,000/mm3; absolute neutrophil count (ANC) >/= 1,500/mm3; platelets >/= 100,000/mm3. - At least three weeks must have elapsed from completion of chemotherapy or radiation therapy. - At least 30 days must have elapsed from completion of treatment with a non-approved or investigational drug. - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol. - Women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy. Exclusion Criteria: - Patients with borderline or low malignant potential tumors are not eligible. - Patients who have had prior therapy with topoisomerase I inhibitors. - Patients who are pregnant or lactating. - Concurrent chemotherapy, radiation therapy, or surgery (excluding palliative radiation). - Concurrent, uncontrolled, medical or psychiatric disorders. - Patients with an active infection. - Patients with a known hypersensitivity to topotecan or iressa. - Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV). - History of other malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 5 years. - Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent. - Patients who have had prior anti-EGFR therapy (i.e. Tarceva, Cetuximab). - Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial. - Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort. - Any evidence of clinically active interstitial lung disease (patient with chronic stable radiographic changes who are asymptomatic are eligible). |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | AstraZeneca, GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity (DLT) | Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any > Grade 3 non-hematologic toxicity. The DLT (dose-limiting toxicity) is defined as any Grade 4 hematological toxicity and any > Grade 3 non-hematologic toxicity. | Continual reassessment method, prior to each 28 day cycle, an average of 60 days | |
Primary | Maximum Tolerated Dose (MTD) of Topotecan | Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT. | At end of first course, prior to each new course (28 day cycle). Continual reassessment method (CRM) during each course for toxicity, an average of 60 days | |
Secondary | Response Rate | Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension. Complete Response (CR): disappearance of all target and non-target lesions and no evidence of new lesions. Partial Response (PR): At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions. Increasing Disease: At least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD or appearance of new lesions within 8 weeks of study entry. Progression on existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin. Death due to disease without prior objective documentation of progression. Global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression. | 61 weeks |
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