Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Vulvar Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

cisplatin

radiation therapy

Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy combined with chemotherapy kills more tumor cells than radiation therapy alone in treating cancer of the vulva.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy with or without cisplatin in treating patients who have stage I, stage II, or stage III cancer of the vulva.

OBJECTIVES:

* Compare the recurrence-free interval and survival in patients with stage I, II, III, or IVA squamous cell carcinoma of the vulva with involved inguinal lymph nodes treated with adjuvant radiotherapy with or without cisplatin.
* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary surgical resection (yes vs no) and node status (N1 vs N2). Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks.
* Arm II: Patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 4.5 years.

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

A Randomized Study of Adjuvant Radiation Treatment Versus Radiation and Chemotherapy in Patients With Vulvar Cancer and Involved Nodes

National Cancer Institute (NCI)

Gynecologic Oncology Group

Sentinel lymph node mapping

Charles Levenback, MD

RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.

PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.

OBJECTIVES:

* Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
* Determine the location of the sentinel node in these patients.

OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.

PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.

Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Symptoms and General Pathology

Recurrence

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

paclitaxel

Els Witteveen, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

OBJECTIVES:

* Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva.
* Determine the objective response rate and duration of response in these patients treated with this drug.
* Determine the acute side effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva

Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced And/Or Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery And/Or Radiotherapy

European Organisation for Research and Treatment of Cancer - EORTC

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Small Cell Lung Carcinoma

Adenocarcinoma

Stomach Neoplasms

Lung Neoplasms

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Anus Diseases

Rectal Diseases

Small Cell Lung Cancer

Stomach Cancer

Penile Cancer

Anal Cancer

Micronutrients

Pharmaceutical Solutions

Hematinics

Vitamins

Leucovorin

Fluorouracil

Irinotecan

Niraparib

Levoleucovorin

Folic Acid

Vitamin B Complex

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Dose escalation of PEN-866 Sodium administered intravenously

Dose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid

Intravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose

Dose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib

PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.

PEN-866 Sodium

fluorouracil

Folinic acid

Tarveda Clinical Information Center

Anish Thomas, MD

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent).

Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy.

Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.

PEN-866 in Patients With Advanced Solid Malignancies

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) will be determined by assessing the incidence of DLTs and treatment related adverse events of PEN-866 as a single agent (Phase 1a) or in combination therapy (Phase 1b).

Safety and tolerability will be determined by assessing the incidence of treatment related adverse events.

Efficacy of PEN-866 in patients with SCLC will be assessed using best overall tumor response rate defined as complete response (CR) or partial response (PR) according to RECIST 1.1.

Efficacy of PEN-866 in patients with gastric or GEJ adenocarcinoma will be assessed using best overall tumor response rate defined as CR or PR according to RECIST 1.1.

Efficacy of PEN-866 in patients with pancreatic adenocarcinoma will be assessed using DCR defined as a best response of CR, PR, or stable disease (SD) according to RECIST 1.1.

Efficacy of PEN-866 in patients with endometrial adenocarcinoma will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.

Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.

Characterize the pharmacokinetic properties of PEN-866 and its components (HSP90 targeting ligand and SN-38)

PK parameters (CMax, AUC) will be evaluated in plasma by standard non-compartmental methods (compartmental modeling may be performed if appropriate).

Size of tumors by CT or MRI using tumor response criteria according to RECIST 1.1 and duration of response.

Efficacy of PEN-866 in combination therapy will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.

Efficacy of PEN-866 in SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of the genitalia (anus, cervix, vulva, and penis) will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.

Efficacy of PEN-866 in pancreatic adenocarcinoma using best overall tumor response rate as defined as CR or PR according to RECIST 1.1

Time from first documented response (CR or PR) to date of first documented disease progression or death due to underlying cancer.

Time from first PEN-866 dose to date of first documented progression or date of death from any cause, whichever came first

Time from first PEN-866 dose to date of death from any cause

Tarveda Therapeutics

Carboplatin

Patients included in the standard treatment arm will receive a combination of weekly cisplatin combined with 30 fractions of external beam radiotherapy on the primary tumour with a total dose of 64.5 Gy. Cisplatin will be given for six weeks intravenously with a dose of 40 mg/m2, if possible on the first day of the week. On day 1 until day 5 the patient will receive external beam radiotherapy. This will be repeated for a six-week period.

Patients included in the experimental arm will be treated with intravenous infusion of paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme with preferably 3 and a maximum of 4 courses, with evaluation after two courses of chemotherapy by physical examination. NACT will be subsequently followed by radical surgery in responding patients. A four to six weeks interval after the last course of chemotherapy needs to be respected before surgery, to allow sufficient physical recovery.

Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme.

Paclitaxel and Carboplatin

Chemoradiation

Frederic Amant, Prof.

F. Amant

L. Nooij

A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma

Proportion of patients free from local-regional progression

Patients without an event will be censored at their last date of contact. The Kaplan-Meier method will be used to estimate freedom from disease-related failure. Difference between the two main treatment arms, NACT vs. chemotherapy, will be tested using a log-rank test. Incidences of disease-related failure will be reported based on the Kaplan-Meier estimates, together with confidence intervals for the hazard ratio using both 90 and 95% confidence levels.

Type of recurrence after treatment: local, regional or distant recurrence

Proportion of patients that don't need adjuvant surgery (arm 1) and number of patients that don't need adjuvant radiotherapy (arm 2)

Proportion of patients for who an organ-sparing surgery is possible

According to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

The Netherlands Cancer Institute

regional lymph node dissection

George C. Lewis, MD

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes.

OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes.

PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva	NCT00006096	Vulvar Cancer	cisplatin radiation thera...	-	GOG Foundation
Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva	NCT00003325	Vulvar Cancer	Sentinel lymph ...	-	GOG Foundation
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva	NCT00014599	Vulvar Cancer	paclitaxel	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva	NCT00006096	Vulvar Cancer	cisplatin radiation thera...	-	GOG Foundation
PEN-866 in Patients With Advanced Solid Malignancies	NCT03221400	Carcinoma Endometrial Ade... Neoplasms Squamous Cell C... Adenocarcinoma ... Advanced Cancer Solid Tumor Solid Carcinoma Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Gastric Cancer Gastric Adenoca... Gastroesophagea... Small-cell Lung... Small Cell Lung... Pancreatic Duct... Pancreatic Aden...	PEN-866 Sodium fluorouracil Folinic acid Niraparib	18 Years -	Tarveda Therapeutics
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC	NCT05905315	Locally Advance... Squamous Cell C...	Paclitaxel and ... Chemoradiation	18 Years -	The Netherlands Cancer Institute
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva	NCT00006096	Vulvar Cancer	cisplatin radiation thera...	-	GOG Foundation
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes	NCT00898352	Vulvar Cancer	regional lymph ... radiation thera...	-	GOG Foundation
Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva	NCT00014599	Vulvar Cancer	paclitaxel	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for squamous cell carcinoma of the vulva