Ramucirumab for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, CT
Adenocarcinoma+23 More
Ramucirumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat gastric or gastroesophageal junction cancer.

See full description

Eligible Conditions

  • Adenocarcinoma
  • Metastatic Esophageal Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Recurrent Gastric Carcinoma
  • Metastatic Gastric Carcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma
  • Stage IIIB Gastric Cancer AJCC v7
  • Recurrent Gastroesophageal Junction Adenocarcinoma
  • Stage IIIA Gastric Cancer AJCC v7
  • Stage III Esophageal Cancer AJCC v7
  • Stage III Gastric Cancer AJCC v7
  • Stage IIIC Gastric Cancer AJCC v7
  • Stage IV Esophageal Cancer AJCC v7
  • Unresectable Esophageal Carcinoma
  • Stage IIIC Esophageal Cancer AJCC v7
  • Stage IIIA Esophageal Cancer AJCC v7
  • Stage IIIB Esophageal Cancer AJCC v7
  • Recurrent Esophageal Carcinoma
  • Stage IV Gastric Cancer AJCC v7
  • Unresectable Gastric Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ramucirumab will improve 2 primary outcomes, 4 secondary outcomes, and 2 other outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 14 days.

Year 6
Progression free survival
Up to 14 days
Dose limiting toxicity and maximum tolerated dose of olaparib (Phase I)
Day 30
Incidence of adverse events
Up to 6 years
BROCA HR assay
BROCA-HR status
Objective response rate (Phase II)
Overall survival
Tumor cells for PDX model, and biobanked tumor tissue and peripheral blood

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Treatment (olaparib, ramucirumab)
1 of 1
Experimental Treatment

This trial requires 49 total participants across 1 different treatment group

This trial involves a single treatment. Ramucirumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (olaparib, ramucirumab)Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
FDA approved
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 years for reporting.

Closest Location

Smilow Cancer Hospital Care Center-Fairfield - Fairfield, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Adenocarcinoma or one of the other 23 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient must have histologically confirmed, gastric carcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ)
The patient has metastatic disease or locally recurrent, unresectable disease. show original
The patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
The patient must have experienced disease progression during or within 4 months after the last dose of chemotherapy for metastatic disease, during or within 6 months after the last dose of adjuvant chemotherapy, or have been intolerant of previous chemotherapy. show original
The patient must have experienced disease progression or intolerance as outlined above after treatment with 1 or more prior chemotherapies. show original
You have had one or more previous treatments. show original
Elevation in tumor markers without radiographic evidence of disease progression is not satisfactory for progression on previous treatment. show original
The patient is >= 18 years of age
The patient has a life expectancy of >= 16 weeks
You have a performance status score of 0-1 (Karnofsky > 60%). show original

Patient Q&A Section

What are common treatments for adenocarcinoma?

"For carcinomas in early and late stages, treatment includes surgery, chemotherapy, hormonal therapy, and immunotherapy. For advanced stages, treatment includes radiation therapy, and, in some cases, medical chemotherapies such as docetaxel, which can be used as a single agent in some stages of advanced disease. The best of these treatments for adenocarcinoma continues to be debated." - Anonymous Online Contributor

Unverified Answer

How many people get adenocarcinoma a year in the United States?

"In 2005, 988,000 cases of adenocarcinoma were reported in the US, making this the second leading type of cancer after Non-Hodgkin lymphoma in men in the United States. The estimated incidence of the disease is 2.2/100,000 men. This number does not account for the number of people at risk who would never experience an instance of the disease. Most cases occur in older men. Adenocarcinoma is the most common cause of prostatic cancer in men over 70 years of age and the only cause of cancer of the prostate in men older than 90 or so. Of these cases, about 70% are diagnosed and around 50% of cases will succumb to the disease." - Anonymous Online Contributor

Unverified Answer

What causes adenocarcinoma?

"There are many causes for adenocarcinoma, including environmental, genetic, and hormonal factors. Tobacco use has been identified for many decades as a major cause of adenocarcinoma with increasing popularity as it is not very expensive and the health consequences are great. Adolescents and young adults are probably the highest-risk groups for adenocarcinoma. To reduce the incidence of adenocarcinoma in all age groups, the risk factors must first be identified. To decrease the incidence of adenocarcinoma in the population generally, [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) programs must be provided to anyone currently smoking. Further investigation is indicated to better understand risk factors for adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

What is adenocarcinoma?

"Adenocarcinoma, also known as adenocarcinoma of the lung or lung cancer, is a carcinoma that arises within the respiratory system. It typically exhibits pleomorphism and is highly variable in its histologic variants. It is a malignant tumor that is typically a cause of death in its untreated state or due to spread from the localized area of its primary tumor. Adenocarcinomas of the lung are much more common than previously thought. It has an age-standardized 5-year incidence of 8.9 new cases per 1000 population and an average mortality rate of 22.4 per 1000 population. It makes up the majority of all lung cancer cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of adenocarcinoma?

"Signs of adenocarcinoma include palpable abdominal mass and/or elevated serum alpha-fetoprotein or carcinoembryonic antigen levels. Symptoms of adenocarcinoma include vague abdominal pain, constipation or difficulty urinating. For adenocarcinomas, the most reliable way to diagnose it is through a biopsy." - Anonymous Online Contributor

Unverified Answer

Can adenocarcinoma be cured?

"Adenocarcinoma of the thyroid is usually curable but the recurrence rate depends on stage and grade of cancer, the presence and extent of multifocality, the nodal or distant metastasis and whether surgery was done." - Anonymous Online Contributor

Unverified Answer

What is ramucirumab?

"Ramuclarumab, a fully human monoclonal antibody targeting PD-1, improves survival and disease progression in patients with refractory advanced squamous non-small cell lung cancer (NSCLC) with poor or no progress during platinum-based chemotherapy." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for adenocarcinoma?

"Based on the results of this study and previous studies, patients who do not have symptoms, or are asymptomatic, may be screened for cancer in an effort to identify asymptomatic cancers and for patients suitable for clinical trials." - Anonymous Online Contributor

Unverified Answer

What does ramucirumab usually treat?

"Ramucirumab is effective and tolerable in patients with metastatic lung cancer, leading to an improvement in overall survival. In this series of patients, more than half had PD-L1 mRNA expression. This supports the role of PD-L1 in the mechanism of action of anti-PD-L1 agents in patients with lung cancer. However, a prospective study in a larger number of patients is warranted." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ramucirumab for therapeutic use?

"This is an extensive review of the current evidence for adenocarcinoma of the lung, with an emphasis on ramucirumab, but similar conclusions can also be drawn for adeno-carcinoma of the breast, renal cancer, and lung squamous cell carcinoma. The recent clinical activity in non-small cell lung cancer with ramucirumab leads to the conclusion that it could still play a major part in the management of this disease. The high overall efficacy and manageable safety profile of this agent provide compelling evidence that it should continue to be explored for therapy of several other cancers as well as for the treatment of advanced NSCLC." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating adenocarcinoma?

"There have been many new methods for the treatment of both adenocarcinoma and adenosquamous carcinoma of the lung, head, or neck. These discoveries allow patients to expect a better quality of life after treatment and allow for surgeons to anticipate a faster recovery. However, these are not guaranteed, as many of the patients suffer relapse when they are treated after these procedures. Additional research to more effectively cure adenocarcinoma, and to prevent relapse, remain crucial." - Anonymous Online Contributor

Unverified Answer

Does adenocarcinoma run in families?

"The frequency of ADH in the first-degree relatives of sporadic pancreatic adenocarcinoma was much higher than previously reported. The frequency of ADH was higher in the members of the first-degree relatives of adenocarcinoma patients. A prospective analysis is required to better clarify the familial pattern and to evaluate the influence of the environmental factors influencing the familial risk of adenocarcinoma of the pancreas." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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