araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and safety of this regimen in these patients. III. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.
  OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD. Patients are followed for 6 weeks.
  PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma Measurable disease No CNS metastasis
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids except for antiemesis or as replacement therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30% of bone marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery unless fully recovered Other: No concurrent vitamin supplements containing folic acid No other concurrent anticancer therapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Summary: RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably.
  PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer.

Detailed description: OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs. continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs. no further treatment.
  OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomized to one of three treatment regimens. The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694 every 21 days for a total of 4 courses. Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy, until evidence of disease progression. Patients are followed every 6 weeks.
  PROJECTED ACCRUAL: A total of 900 patients will be entered.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum in one of the following categories: Locally advanced, metastatic, or recurrent disease suitable only for palliative chemotherapy Evaluable disease outside prior radiotherapy field Patients with disease confined to the liver are referred to protocol MRC-CR05
  PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 4,000 ANC at least 2,000 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 65 mL/min Cardiovascular: No uncontrolled heart failure No uncontrolled angina Other: No uncontrolled medical illness (including infection) Able and willing to complete quality-of-life questionnaires No prior or concurrent malignancy likely to interfere with protocol treatment or evaluation
  PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy except fluorouracil-based adjuvant regimen (e.g., QUASAR) At least 6 months since chemotherapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin calcium, and gemcitabine in these patients.
  OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to be considered evaluable for response. Patients with stable disease, partial, or complete remission may continue therapy for up to six treatment cycles. Patients exhibiting disease progression or intolerable toxic effects are removed from the study.
  PROJECTED ACCRUAL: A total of 63 patients will be accrued.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic primary colorectal carcinoma Must have measurable disease (evaluable disease acceptable in Phase I)
  PATIENT CHARACTERISTICS: Age: Not specified Performance Status: ECOG 0-3 Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL OR 3.0 mg/dL in patients with liver metastases Liver enzymes no greater than 3.0 times upper limit of normal (in patients with liver metastases) Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for metastatic disease allowed Prior treatment with 5-FU allowed Prior treatment with irinotecan allowed Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy (measurable disease must be located outside the prior radiotherapy portal) Surgery: Not specified Other: Prior treatment with folinic acid allowed

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Irofulven in Treating Patients With Metastatic Colorectal Cancer

Summary: 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 irofulven in treating patients with metastatic colorectal cancer.

Detailed description: OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene (MGI-114) when given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon or rectum. II. Evaluate the qualitative and quantitative toxicities of MGI-114 given on this schedule in this patient population.
  OUTLINE: Patients receive 6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days. Courses are repeated every 28 days. The minimum treatment period is 2 courses. Treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression. Patients are followed at the end of every other course while on the study, and then every 3 months thereafter until death.
  PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-10 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Bidimensionally measurable lesions Sentinel lesions outside the field of any prior radiation therapy No confirmed or suspected brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis or mental disability No life threatening illness (unrelated to tumor)
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation therapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: At least 28 days since prior administration of any investigational drug No other concurrent anticancer therapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Genetic Study in Patients With Stage II or Stage III Colon Cancer

Summary: RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.
  PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.

Detailed description: OBJECTIVES:
  -  Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
  -  Determine if patient prognosis is dependent on the region of 8p AI.
  -  Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
  -  Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.
  OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of resectable stage II or III adenocarcinoma of the colon
  -  Participated in NCCTG-914653
  -  DNA extracted from both normal and tumor tissue
  PATIENT CHARACTERISTICS:
  Age
  -  Under 70

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

Summary: RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.
  PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.

Detailed description: OBJECTIVES:
  -  Determine the objective response and clinical outcome in patients with colonic obstruction secondary to malignancy treated with enteral Wallstents.
  -  Evaluate the efficacy and safety of this treatment in these patients.
  -  Evaluate the quality of life of these patients after enteral Wallstent placement.
  OUTLINE: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.
  Quality of life is assessed at 48 hours and 6 months after the procedure.
  Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Endoscopically confirmed localized tumor as the cause of colonic obstruction
  -  All primary tumor types are eligible
  -  No prior colonic Wallstents
  -  Must have symptoms of gastrointestinal obstruction, including:
  -  Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-3
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count greater than 50,000/mm^3
  Hepatic:
  -  INR no greater than 1.5 times upper limit of normal
  Renal:
  -  Not specified
  Cardiovascular:
  -  No cardiac condition
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy
  -  No other serious concurrent illness
  -  No uncontrolled metabolic disease (e.g., diabetes or hypothyroidism)
  -  No dementia, psychiatric disorder, or altered mental status that would preclude compliance
  -  History of other neoplastic disease allowed
  -  Veterans Administration patients are not eligible
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Prior or concurrent chemotherapy allowed
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior or concurrent radiotherapy allowed
  Surgery:
  -  At least 3 weeks since prior surgery and recovered

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Genetic Markers in Patients With Colorectal Cancer

Summary: RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse.
  PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer.

Detailed description: OBJECTIVES:
  -  Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer (tumor microsatellite instability).
  -  Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5, 8, 17, and 18 (as the primary targets) and of chromosomes 1, 14, and 22 (as the secondary targets) in colorectal cancer.
  OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2).
  Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
  PROJECTED ACCRUAL: This study will accrue up to 708 specimens.

Eligibility: DISEASE CHARACTERISTICS:
  -  Must have had a resectable adenocarcinoma of the colon or rectum and must have participated in one of the following NCCTG randomized clinical trials:
  -  784852: No Treatment Control Versus Levamisole Versus Levamisole Plus Fluorouracil (5-FU)
  -  794604: No Treatment Control Versus 5-FU by Portal Vein Infusion
  -  794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU
  -  844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  -  864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy
  -  874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  -  894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer
  -  Tissue blocks from the primary colorectal cancer must have been received by the NCCTG operations office

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: EPO906 Therapy in Patients With Advanced Colorectal Cancer

Summary: This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause colorectal cancer.


Eligibility: Inclusion Criteria
  Patients must meet the following criteria to be eligible for the study:
  -  Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  -  The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin)
  -  Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol
  -  Must have a life expectancy of greater than three (3) months.
  Exclusion Criteria
  The following patients are not eligible for the study:
  -  Patients with symptomatic CNS metastases or leptomeningeal involvement
  -  Patients with unresolved bowel obstruction
  -  Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  -  Patients with severe cardiac insufficiency
  -  Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
  -  Patients with radiation therapy or chemotherapy within the last four weeks
  -  Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  -  History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  -  Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  -  HIV+ patients
  -  Pregnant or lactating females

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Summary: This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.


Eligibility: Inclusion criteria:
  -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
  -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  -  Adequate renal, hepatic and cardiac function
  Exclusion criteria:
  -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
  -  Patients with active brain metastases
  -  Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Relevance to patient case: not relevant