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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to determine the safest and maximum tolerated dosing regimens for intraperitoneal oxaliplatin with intravenous docetaxel and intravenous oxaliplatin with intraperitoneal docetaxel for recurrent ovarian, primary peritoneal, or fallopian tube cancer.
This is a non-randomized, open-label Phase I trial in patients with previously treated, recurrent ovarian, primary peritoneal, or fallopian tube cancer. Patients may have either platinum -sensitive (relapse > 12 months from primary therapy) or platinum-resistant (relapse ≤ 12 months from primary therapy) disease.
Up to 20 patients will be enrolled into each of the following arms:
Treatment will be repeated every 3 weeks until disease progression, intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | intravenous (IV) docetaxel and intraperitoneal (IP) oxaliplatin |
|
| 2 | Experimental | intravenous (IV) oxaliplatin and intraperitoneal(IP) docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous docetaxel with intraperitoneal oxaliplatin | Drug | IV docetaxel 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal oxaliplatin escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safest and maximum tolerated dose regimen for IV oxaliplatin with intraperitoneal docetaxel and IV oxaliplatin with intraperitoneal docetaxel in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess quality of life | 18 months |
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Inclusion Criteria:
Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
Subjects may not have had > 3 prior regimens and must not have had a platinum or taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks prior to enrollment. Subjects may not have had prior whole abdomen or pelvic radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2 of doxorubicin.
ECOG Performance Score of ≤2 (Appendix A)
Adequate bone marrow as evidenced by:
Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
Adequate hepatic function as evidenced by:
Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Edwards, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Kristin Zorn, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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|
| intravenous oxaliplatin with intraperitoneal docetaxel | Drug | IV oxaliplatin 75 mg/m2 over 1 hour on day #1 followed by intraperitoneal docetaxel escalating from 50 mg/m2 on day #2. Cycles of treatment will be repeated every 3 weeks until disease progression or intolerable toxicity occurs. |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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