Completed

Carboplatin and Paclitaxel With or Without Bevacizumab Compared to Docetaxel, Carboplatin, and Paclitaxel in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Carcinoma (Cancer)

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What is being tested

carboplatin

+ paclitaxel
+ docetaxel
Drug
Biological
Who is being recruted

Brenner Tumor
+10

+ Fallopian Tube Cancer
+ Ovarian Carcinosarcoma
Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: July 22, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma 
Principal SponsorNational Cancer Institute (NCI)
Last updated: July 22, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brenner Tumor
Fallopian Tube Cancer
Ovarian Carcinosarcoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage II Ovarian Epithelial Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Criteria

Inclusion Criteria: * Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma * Stage II-IV disease * The following epithelial cell types are allowed: * Carcinosarcoma * Serous adenocarcinoma * Endometrioid adenocarcinoma * Mucinous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Transitional cell carcinoma * Malignant Brenner's tumor * Adenocarcinoma not otherwise specified * Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks * Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery * Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation * Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met: * Stage ≤ IB * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous) * No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas) * No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis * GOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) (applies to part C only) * PTT \< 1.2 times the upper limit of normal (applies to part C only) * SGOT ≤ 2.5 times normal * Alkaline phosphatase ≤ 2.5 times normal * Bilirubin ≤ 1.5 times normal * Creatinine ≤ 1.5 times normal * No active bleeding * Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months * No unstable angina or myocardial infarction within the past 6 months * No neuropathy (sensory and motor) \> CTCAE grade 1 * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy * No septicemia, severe infection, or acute hepatitis * No other invasive malignancy within the past 5 years except non-melanoma skin cancer or localized breast cancer * No circumstance that would preclude study participation * No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies (applies to part C only) * No clinically significant proteinuria * Must have urine protein-creatinine ratio (UPCR) \< 1 * No serious, non-healing wound, ulcer, or bone fracture (applies to part C only) * At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and fully recovered (part C only) * No history of intra-abdominal abscess within the past 28 days (applies to part C only) * No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to part C only) * No history or evidence (upon physical examination) of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases (applies to part C only) * No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study (applies to part C only) * No significant traumatic injury within 28 days (applies to part C only) * No clinically significant cardiovascular disease, including any of the following (applies to part C only): * Uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina \< 6 months prior to registration * New York Heart Association (NYHA) Grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication * CTCAE Grade 2 or greater peripheral vascular disease (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) * History of CVA within the past six months * No clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition (applies to part C only) * No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C only) * No prior chemotherapy * Prior adjuvant chemotherapy for localized breast cancer allowed provided the therapy was completed at least 3 years before registration to study and the patient remains free of recurrent or metastatic disease * No prior radiotherapy * No prior cancer therapy that would contraindicate study treatment * No anticipation of invasive procedures, including any of the following (applies to part C only): * Major surgical procedure or open biopsy within 28 days prior to the first date of bevacizumab therapy (cycle 2) * Major surgical procedure anticipated during the course of the study * Core biopsy within 7 days prior to the first date of bevacizumab therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 16 locations
Suspended
University of California Medical Center At Irvine-Orange CampusOrange, United StatesSee the location
Suspended
Colorado Gynecologic Oncology GroupAurora, United States
Suspended
University of Chicago Comprehensive Cancer CenterChicago, United States
Suspended
University of Iowa Hospitals and ClinicsIowa City, United States

Completed16 Study Centers