A Phase 1 interventional study of carboplatin and paclitaxel in Brenner Tumor, Fallopian Tube Cancer and Ovarian Carcinosarcoma, sponsored by National Cancer Institute (NCI). Completed at 16 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial is studying the side effects and best dose of intraperitoneal infusions of carboplatin when given together with intravenous infusions of either docetaxel or paclitaxel followed by intraperitoneal paclitaxel in treating patients with stage II, stage III, or stage IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma (cancer). Drugs used in chemotherapy, such as carboplatin, docetaxel, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of intraperitoneal (IP) carboplatin when given in combination with IV paclitaxel followed by IP paclitaxel in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma.
II. Determine the MTD of IP carboplatin and IV docetaxel when given in combination with IP paclitaxel in these patients.
III. To determine the feasibility of the combination of IV paclitaxel, IP carboplatin and IV bevacizumab on day one followed by IP paclitaxel on day eight (Part C Only).
IV. Determine the dose-limiting toxic effects and complications in patients treated with these regimens.
V. Evaluate the neurotoxicity of this regimen at each cycle using the FACT/GOG-NTX4 assessment tool to determine dose reduction in these patients.
VI. Evaluate the techniques used for intraperitoneal catheter placement, surgical procedures, and reporting of outcomes in these patients.
OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal (IP) carboplatin.
Patients in the dose-escalation phase are not eligible to enter the feasibility phase.
DOSE-ESCALATION PHASE (PART A or PART B): Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
FEASIBILITY PHASE (PART C): Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
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This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Inclusion Criteria:
Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma
The following epithelial cell types are allowed:
Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks
Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met:
No clinically significant proteinuria
No clinically significant cardiovascular disease, including any of the following (applies to part C only):
No prior chemotherapy
No anticipation of invasive procedures, including any of the following (applies to part C only):
Patients receive IP carboplatin on day 1, and paclitaxel IV over 3 hour (part A) or docetaxel IV over 1 hour (Part B) on day 1, and IP paclitaxel on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive IP carboplatin on day 1, paclitaxel IV on day 1, and IP paclitaxel on day 8 in course 1 as in part A dose-escalation phase. Beginning in course 2 and all subsequent courses, patients receive IP carboplatin on day 1, IV paclitaxel on day 1, and IP paclitaxel on day 8 as in the dose-escalation phase, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin · Drug: paclitaxel · Drug: docetaxel · Biological: bevacizumab
Given intraperitoneally
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV or intraperitoneally
Also known as: Anzatax, Asotax, TAX, Taxol
Given IV
Also known as: RP 56976, Taxotere, TXT
Given IV
Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Maximum tolerated dose (MTD) of IV paclitaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time frame: 3 weeks
MTD of IV docetaxel with IP carboplatin followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
Time frame: 3 weeks
MTD of IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel, determined according to dose-limiting toxicities (DLTs) graded using CTCAE v3.0
Time frame: 3 weeks
Incidence of adverse events in patients given IV paclitaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
Time frame: 12 weeks
Incidence of adverse events in patients given of IV docetaxel with IP carboplatin followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
Time frame: 12 weeks
Incidence of adverse events in patients given IV paclitaxel with IP carboplatin and IV bevacizumab followed by IP paclitaxel at the MTD, assessed by CTCAE v3.0
Time frame: 12 weeks
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)